FDA approves first internal tissue adhesive for use in abdominoplasty

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FDA approves first internal tissue adhesive for use in abdominoplasty

The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.

The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”

The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.

Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.

Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.

TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.

Information on the approval, as well as patient and physician labeling, is available on the FDA website.

[email protected]

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The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.

The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”

The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.

Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.

Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.

TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.

Information on the approval, as well as patient and physician labeling, is available on the FDA website.

[email protected]

The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.

The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”

The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.

Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.

Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.

TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.

Information on the approval, as well as patient and physician labeling, is available on the FDA website.

[email protected]

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FDA approves palbociclib with letrozole for advanced postmenopausal breast cancer

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FDA approves palbociclib with letrozole for advanced postmenopausal breast cancer

Palbociclib, a cyclin-dependent kinase 4/6 inhibitor, has been approved by the Food and Drug Administration for treating postmenopausal women with estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease, in combination with letrozole.

The accelerated approval was based on a randomized phase II study of 165 postmenopausal women with ER-positive, HER2-negative metastatic breast cancer, who had not been treated for advanced disease, in which investigators found a progression-free survival rate of about 20.2 months among the women treated with the combination, compared with about 10.2 months among those treated with letrozole, an aromatase inhibitor, alone. Overall survival results are not yet available, according to the Feb. 3 Food and Drug Administration statement announcing the approval.

Dr. Richard Pazdur

“The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. Palbociclib was approved under the FDA Accelerated Approval Program, which “allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients,” and makes the drug available to patients earlier while the manufacturer conducts trials to confirm the benefits, according to the FDA. The indications and usage section of the prescribing information includes the statement that “continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”

© 2014 AACR/Todd Buchanan
Dr. Richard S. Finn

Neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, lack of energy and asthenia, peripheral neuropathy, and epistaxis were the most common adverse effects associated with treatment, according to the FDA statement.

“Healthcare professionals are advised to monitor complete blood count prior to start of therapy and at the beginning of each cycle, as well as on day 14 of the first two cycles, and as clinically indicated,” the statement said.

The recommended starting dose for palbociclib is 125 mg once a day (with food) for 21 days followed by 7 days off treatment.

Palbociclib inhibits cyclin-dependent kinase (CDK) 4 and 6, involved in promoting the growth of cancer cells. Letrozole (Femara), also taken orally, is approved for treatment of breast cancer in postmenopausal women, as adjuvant treatment for hormone receptor–positive early breast cancer, extended adjuvant treatment of early breast cancer for patients who have received prior standard adjuvant tamoxifen therapy, and as first- and second-line treatment of hormone receptor–positive or unknown advanced breast cancer.

Dr. Dennis J. Slamon

In a statement released by the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, the principal investigator of the study that led to the approval, Dr. Richard S. Finn, pointed out that palbociclib is the first drug in its class to be approved. In the statement, Dr. Dennis J. Slamon, director of the Revlon/UCLA Women’s Cancer Research Program and Clinical/Translational Research at the Jonsson Cancer Center, said that he believes that palbociclib will become “a standard treatment approach for postmenopausal women with ER+/HER2– metastatic breast cancer.” He added that the magnitude of the benefit seen in the phase II study “was very gratifying and reminiscent of results we saw when we conducted the initial studies on Herceptin in HER2+ breast cancers 2 decades ago.”

Dr. Finn reported the of the phase II study at the annual meeting of the American Association for Cancer Research in April. He and Dr. Slamon are investigators in the phase III confirmatory trial of palbociclib in over 600 women, which has completed enrollment, according to the UCLA release.

Pfizer will market palbociclib as Ibrance.

[email protected]

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Palbociclib, a cyclin-dependent kinase 4/6 inhibitor, has been approved by the Food and Drug Administration for treating postmenopausal women with estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease, in combination with letrozole.

The accelerated approval was based on a randomized phase II study of 165 postmenopausal women with ER-positive, HER2-negative metastatic breast cancer, who had not been treated for advanced disease, in which investigators found a progression-free survival rate of about 20.2 months among the women treated with the combination, compared with about 10.2 months among those treated with letrozole, an aromatase inhibitor, alone. Overall survival results are not yet available, according to the Feb. 3 Food and Drug Administration statement announcing the approval.

Dr. Richard Pazdur

“The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. Palbociclib was approved under the FDA Accelerated Approval Program, which “allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients,” and makes the drug available to patients earlier while the manufacturer conducts trials to confirm the benefits, according to the FDA. The indications and usage section of the prescribing information includes the statement that “continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”

© 2014 AACR/Todd Buchanan
Dr. Richard S. Finn

Neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, lack of energy and asthenia, peripheral neuropathy, and epistaxis were the most common adverse effects associated with treatment, according to the FDA statement.

“Healthcare professionals are advised to monitor complete blood count prior to start of therapy and at the beginning of each cycle, as well as on day 14 of the first two cycles, and as clinically indicated,” the statement said.

The recommended starting dose for palbociclib is 125 mg once a day (with food) for 21 days followed by 7 days off treatment.

Palbociclib inhibits cyclin-dependent kinase (CDK) 4 and 6, involved in promoting the growth of cancer cells. Letrozole (Femara), also taken orally, is approved for treatment of breast cancer in postmenopausal women, as adjuvant treatment for hormone receptor–positive early breast cancer, extended adjuvant treatment of early breast cancer for patients who have received prior standard adjuvant tamoxifen therapy, and as first- and second-line treatment of hormone receptor–positive or unknown advanced breast cancer.

Dr. Dennis J. Slamon

In a statement released by the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, the principal investigator of the study that led to the approval, Dr. Richard S. Finn, pointed out that palbociclib is the first drug in its class to be approved. In the statement, Dr. Dennis J. Slamon, director of the Revlon/UCLA Women’s Cancer Research Program and Clinical/Translational Research at the Jonsson Cancer Center, said that he believes that palbociclib will become “a standard treatment approach for postmenopausal women with ER+/HER2– metastatic breast cancer.” He added that the magnitude of the benefit seen in the phase II study “was very gratifying and reminiscent of results we saw when we conducted the initial studies on Herceptin in HER2+ breast cancers 2 decades ago.”

Dr. Finn reported the of the phase II study at the annual meeting of the American Association for Cancer Research in April. He and Dr. Slamon are investigators in the phase III confirmatory trial of palbociclib in over 600 women, which has completed enrollment, according to the UCLA release.

Pfizer will market palbociclib as Ibrance.

[email protected]

Palbociclib, a cyclin-dependent kinase 4/6 inhibitor, has been approved by the Food and Drug Administration for treating postmenopausal women with estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease, in combination with letrozole.

The accelerated approval was based on a randomized phase II study of 165 postmenopausal women with ER-positive, HER2-negative metastatic breast cancer, who had not been treated for advanced disease, in which investigators found a progression-free survival rate of about 20.2 months among the women treated with the combination, compared with about 10.2 months among those treated with letrozole, an aromatase inhibitor, alone. Overall survival results are not yet available, according to the Feb. 3 Food and Drug Administration statement announcing the approval.

Dr. Richard Pazdur

“The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. Palbociclib was approved under the FDA Accelerated Approval Program, which “allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients,” and makes the drug available to patients earlier while the manufacturer conducts trials to confirm the benefits, according to the FDA. The indications and usage section of the prescribing information includes the statement that “continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”

© 2014 AACR/Todd Buchanan
Dr. Richard S. Finn

Neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, lack of energy and asthenia, peripheral neuropathy, and epistaxis were the most common adverse effects associated with treatment, according to the FDA statement.

“Healthcare professionals are advised to monitor complete blood count prior to start of therapy and at the beginning of each cycle, as well as on day 14 of the first two cycles, and as clinically indicated,” the statement said.

The recommended starting dose for palbociclib is 125 mg once a day (with food) for 21 days followed by 7 days off treatment.

Palbociclib inhibits cyclin-dependent kinase (CDK) 4 and 6, involved in promoting the growth of cancer cells. Letrozole (Femara), also taken orally, is approved for treatment of breast cancer in postmenopausal women, as adjuvant treatment for hormone receptor–positive early breast cancer, extended adjuvant treatment of early breast cancer for patients who have received prior standard adjuvant tamoxifen therapy, and as first- and second-line treatment of hormone receptor–positive or unknown advanced breast cancer.

Dr. Dennis J. Slamon

In a statement released by the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, the principal investigator of the study that led to the approval, Dr. Richard S. Finn, pointed out that palbociclib is the first drug in its class to be approved. In the statement, Dr. Dennis J. Slamon, director of the Revlon/UCLA Women’s Cancer Research Program and Clinical/Translational Research at the Jonsson Cancer Center, said that he believes that palbociclib will become “a standard treatment approach for postmenopausal women with ER+/HER2– metastatic breast cancer.” He added that the magnitude of the benefit seen in the phase II study “was very gratifying and reminiscent of results we saw when we conducted the initial studies on Herceptin in HER2+ breast cancers 2 decades ago.”

Dr. Finn reported the of the phase II study at the annual meeting of the American Association for Cancer Research in April. He and Dr. Slamon are investigators in the phase III confirmatory trial of palbociclib in over 600 women, which has completed enrollment, according to the UCLA release.

Pfizer will market palbociclib as Ibrance.

[email protected]

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Improved version of gastric stimulator for gastroparesis approved as humanitarian device

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Improved version of gastric stimulator for gastroparesis approved as humanitarian device

An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

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An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

[email protected]

An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

[email protected]

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FDA approves empagliflozin-linagliptin combo tablet

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A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.

The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.

Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).

Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.

The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.

The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.

Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.

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A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.

The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.

Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).

Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.

The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.

The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.

Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.

[email protected]

A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.

The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.

Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).

Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.

The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.

The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.

Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.

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Abuse-deterrent formulation of extended-release hydrocodone approved

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A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

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A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

[email protected]

A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

[email protected]

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CNS stimulant is first drug approved for binge-eating disorder

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Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

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Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

[email protected]

Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

[email protected]

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JAK inhibitor more effective than standard therapy for polycythemia vera

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JAK inhibitor more effective than standard therapy for polycythemia vera

Treatment with ruxolitinib, an oral inhibitor of Janus kinase 1 and 2, was associated with significantly better responses and improvement in symptoms in patients with polycythemia vera who had not responded to or had experienced unacceptable side effects with hydroxyurea, compared with those who received standard therapy, in a phase III, open-label study, Dr. Alessandro Vannucchi of the University of Florence (Italy) and his associates reported.

In the RESPONSE study, patients with splenomegaly who required phlebotomy for control of hematocrit and had an inadequate response or had experienced unacceptable side effects with hydroxyurea were randomized to treatment with the kinase inhibitor (110 patients) or to interferon and other standard treatments (112). After 32 weeks, 21% of those treated with ruxolitinib had met the primary endpoint, which was control of hematocrit and at least a 35% reduction in spleen volume (measured by MRI or CT), compared with 1% of those on standard treatment, a statistically significant difference with a P value less than .001. A significantly greater proportion of those in the ruxolitinib-treated group also met the two individual components of the primary endpoint.

“Response rates with ruxolitinib were similar among patients who had unacceptable side effects from hydroxyurea and those who had an inadequate response to hydroxyurea. ... and there was no relationship between response and age, sex, or baseline spleen volume,” the authors wrote. The study is the basis of the recent Food and Drug Administration approval of ruxolitinib for this indication (N. Engl. J. Med. 2015 Jan. 28. [doi:10.1056/NEJMoa1409002])Other endpoints included complete hematologic remission, achieved by 24% of those treated with ruxolitinib vs. 9% on standard therapy. At week 32, almost half of those on ruxolitinib had at least a 50% reduction in the total symptom score that assessed disease-related symptoms vs. 5% of those on standard therapy.

Some hematologic adverse events were more common among those on ruxolitinib: 2% developed grade 3 or 4 anemia, and 5% developed grade 3 or 4 thrombocytopenia, compared with 0% and 4% of those on standard treatment. In addition, 6% of those on ruxolitinib developed herpes zoster infections, compared with none of those on standard therapy. One patient on ruxolitinib and six patients on standard therapy had thromboembolic events. Three patients treated with ruxolitinib developed myelofibrosis 120-469 days after being randomized to treatment (about 5-9 years after they had been diagnosed with polycythemia vera) and one patient was diagnosed with acute myeloid leukemia after 56 days of treatment. Among those on standard therapy, one patient developed myelofibrosis after 101 days of treatment and two were diagnosed with myelofibrosis more than 300 days after they crossed over to treatment with ruxolitinib, including one patient who progressed to acute myelogenous leukemia.

While many patients with polycythemia vera respond adequately to hydroxyurea, the most commonly used cytoreductive agent used to treat polycythemia vera, about 25% do not have a satisfactory response or experience unacceptable side effects, “and alternative treatment options are needed for these patients,” the authors said.

The mean age of the patients in the study was 60-62 years, and they had been diagnosed with polycythemia vera a median of 8-9 years previously; 60% of those in the ruxolitinib group and 71% in the standard therapy group were men. The investigators chose the standard therapy, which included hydroxyurea at a dose that did not result in unacceptable side effects (59%), interferon (12%), anagrelide (7%), immunomodulators (4.5%), and pipobroman (2%); and in about 15% of patients, no medication was given.

Ruxolitinib was approved by the Food and Drug Administration in December 2014 for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. It was initially approved by the FDA in 2011, for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post polycythemia vera myelofibrosis, and post essential thrombocythemia myelofibrosis.

Ruxolitinib inhibits Janus kinase (JAK) 1 and JAK2, which “mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function,” according to the prescribing information. It is marketed as Jakafi by Incyte.

Most of the patients on ruxolitinib are continuing treatment in the RESPONSE study, which is ongoing but is not recruiting any more patients, according to the authors.

The study was sponsored by Incyte and Novartis, which has licensed ruxolitinib from Incyte for development and commercialization outside the United States. Dr. Vannucchi disclosed having received grant support and serving as an adviser for Novartis; three authors are employees of Incyte; three are employees of Novartis in the United States or Switzerland, six authors had no disclosures, and one author received grants from Incyte during the study. The remaining three authors reported serving on the advisory board, serving as speakers or lecturers, and/or receiving grant support from Novartis.

 

 

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Treatment with ruxolitinib, an oral inhibitor of Janus kinase 1 and 2, was associated with significantly better responses and improvement in symptoms in patients with polycythemia vera who had not responded to or had experienced unacceptable side effects with hydroxyurea, compared with those who received standard therapy, in a phase III, open-label study, Dr. Alessandro Vannucchi of the University of Florence (Italy) and his associates reported.

In the RESPONSE study, patients with splenomegaly who required phlebotomy for control of hematocrit and had an inadequate response or had experienced unacceptable side effects with hydroxyurea were randomized to treatment with the kinase inhibitor (110 patients) or to interferon and other standard treatments (112). After 32 weeks, 21% of those treated with ruxolitinib had met the primary endpoint, which was control of hematocrit and at least a 35% reduction in spleen volume (measured by MRI or CT), compared with 1% of those on standard treatment, a statistically significant difference with a P value less than .001. A significantly greater proportion of those in the ruxolitinib-treated group also met the two individual components of the primary endpoint.

“Response rates with ruxolitinib were similar among patients who had unacceptable side effects from hydroxyurea and those who had an inadequate response to hydroxyurea. ... and there was no relationship between response and age, sex, or baseline spleen volume,” the authors wrote. The study is the basis of the recent Food and Drug Administration approval of ruxolitinib for this indication (N. Engl. J. Med. 2015 Jan. 28. [doi:10.1056/NEJMoa1409002])Other endpoints included complete hematologic remission, achieved by 24% of those treated with ruxolitinib vs. 9% on standard therapy. At week 32, almost half of those on ruxolitinib had at least a 50% reduction in the total symptom score that assessed disease-related symptoms vs. 5% of those on standard therapy.

Some hematologic adverse events were more common among those on ruxolitinib: 2% developed grade 3 or 4 anemia, and 5% developed grade 3 or 4 thrombocytopenia, compared with 0% and 4% of those on standard treatment. In addition, 6% of those on ruxolitinib developed herpes zoster infections, compared with none of those on standard therapy. One patient on ruxolitinib and six patients on standard therapy had thromboembolic events. Three patients treated with ruxolitinib developed myelofibrosis 120-469 days after being randomized to treatment (about 5-9 years after they had been diagnosed with polycythemia vera) and one patient was diagnosed with acute myeloid leukemia after 56 days of treatment. Among those on standard therapy, one patient developed myelofibrosis after 101 days of treatment and two were diagnosed with myelofibrosis more than 300 days after they crossed over to treatment with ruxolitinib, including one patient who progressed to acute myelogenous leukemia.

While many patients with polycythemia vera respond adequately to hydroxyurea, the most commonly used cytoreductive agent used to treat polycythemia vera, about 25% do not have a satisfactory response or experience unacceptable side effects, “and alternative treatment options are needed for these patients,” the authors said.

The mean age of the patients in the study was 60-62 years, and they had been diagnosed with polycythemia vera a median of 8-9 years previously; 60% of those in the ruxolitinib group and 71% in the standard therapy group were men. The investigators chose the standard therapy, which included hydroxyurea at a dose that did not result in unacceptable side effects (59%), interferon (12%), anagrelide (7%), immunomodulators (4.5%), and pipobroman (2%); and in about 15% of patients, no medication was given.

Ruxolitinib was approved by the Food and Drug Administration in December 2014 for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. It was initially approved by the FDA in 2011, for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post polycythemia vera myelofibrosis, and post essential thrombocythemia myelofibrosis.

Ruxolitinib inhibits Janus kinase (JAK) 1 and JAK2, which “mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function,” according to the prescribing information. It is marketed as Jakafi by Incyte.

Most of the patients on ruxolitinib are continuing treatment in the RESPONSE study, which is ongoing but is not recruiting any more patients, according to the authors.

The study was sponsored by Incyte and Novartis, which has licensed ruxolitinib from Incyte for development and commercialization outside the United States. Dr. Vannucchi disclosed having received grant support and serving as an adviser for Novartis; three authors are employees of Incyte; three are employees of Novartis in the United States or Switzerland, six authors had no disclosures, and one author received grants from Incyte during the study. The remaining three authors reported serving on the advisory board, serving as speakers or lecturers, and/or receiving grant support from Novartis.

 

 

[email protected]

Treatment with ruxolitinib, an oral inhibitor of Janus kinase 1 and 2, was associated with significantly better responses and improvement in symptoms in patients with polycythemia vera who had not responded to or had experienced unacceptable side effects with hydroxyurea, compared with those who received standard therapy, in a phase III, open-label study, Dr. Alessandro Vannucchi of the University of Florence (Italy) and his associates reported.

In the RESPONSE study, patients with splenomegaly who required phlebotomy for control of hematocrit and had an inadequate response or had experienced unacceptable side effects with hydroxyurea were randomized to treatment with the kinase inhibitor (110 patients) or to interferon and other standard treatments (112). After 32 weeks, 21% of those treated with ruxolitinib had met the primary endpoint, which was control of hematocrit and at least a 35% reduction in spleen volume (measured by MRI or CT), compared with 1% of those on standard treatment, a statistically significant difference with a P value less than .001. A significantly greater proportion of those in the ruxolitinib-treated group also met the two individual components of the primary endpoint.

“Response rates with ruxolitinib were similar among patients who had unacceptable side effects from hydroxyurea and those who had an inadequate response to hydroxyurea. ... and there was no relationship between response and age, sex, or baseline spleen volume,” the authors wrote. The study is the basis of the recent Food and Drug Administration approval of ruxolitinib for this indication (N. Engl. J. Med. 2015 Jan. 28. [doi:10.1056/NEJMoa1409002])Other endpoints included complete hematologic remission, achieved by 24% of those treated with ruxolitinib vs. 9% on standard therapy. At week 32, almost half of those on ruxolitinib had at least a 50% reduction in the total symptom score that assessed disease-related symptoms vs. 5% of those on standard therapy.

Some hematologic adverse events were more common among those on ruxolitinib: 2% developed grade 3 or 4 anemia, and 5% developed grade 3 or 4 thrombocytopenia, compared with 0% and 4% of those on standard treatment. In addition, 6% of those on ruxolitinib developed herpes zoster infections, compared with none of those on standard therapy. One patient on ruxolitinib and six patients on standard therapy had thromboembolic events. Three patients treated with ruxolitinib developed myelofibrosis 120-469 days after being randomized to treatment (about 5-9 years after they had been diagnosed with polycythemia vera) and one patient was diagnosed with acute myeloid leukemia after 56 days of treatment. Among those on standard therapy, one patient developed myelofibrosis after 101 days of treatment and two were diagnosed with myelofibrosis more than 300 days after they crossed over to treatment with ruxolitinib, including one patient who progressed to acute myelogenous leukemia.

While many patients with polycythemia vera respond adequately to hydroxyurea, the most commonly used cytoreductive agent used to treat polycythemia vera, about 25% do not have a satisfactory response or experience unacceptable side effects, “and alternative treatment options are needed for these patients,” the authors said.

The mean age of the patients in the study was 60-62 years, and they had been diagnosed with polycythemia vera a median of 8-9 years previously; 60% of those in the ruxolitinib group and 71% in the standard therapy group were men. The investigators chose the standard therapy, which included hydroxyurea at a dose that did not result in unacceptable side effects (59%), interferon (12%), anagrelide (7%), immunomodulators (4.5%), and pipobroman (2%); and in about 15% of patients, no medication was given.

Ruxolitinib was approved by the Food and Drug Administration in December 2014 for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. It was initially approved by the FDA in 2011, for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post polycythemia vera myelofibrosis, and post essential thrombocythemia myelofibrosis.

Ruxolitinib inhibits Janus kinase (JAK) 1 and JAK2, which “mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function,” according to the prescribing information. It is marketed as Jakafi by Incyte.

Most of the patients on ruxolitinib are continuing treatment in the RESPONSE study, which is ongoing but is not recruiting any more patients, according to the authors.

The study was sponsored by Incyte and Novartis, which has licensed ruxolitinib from Incyte for development and commercialization outside the United States. Dr. Vannucchi disclosed having received grant support and serving as an adviser for Novartis; three authors are employees of Incyte; three are employees of Novartis in the United States or Switzerland, six authors had no disclosures, and one author received grants from Incyte during the study. The remaining three authors reported serving on the advisory board, serving as speakers or lecturers, and/or receiving grant support from Novartis.

 

 

[email protected]

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Key clinical point: Ruxolitinib, now approved for treatment of polycythemia vera in the United States, is an alternative to hydroxyurea in patients who have failed treatment with or cannot tolerate hydroxyurea.

Major finding: After 8 months, treatment with ruxolitinib resulted in significantly better responses than standard therapy in patients with polycythemia vera who had an unsatisfactory response or unacceptable side effects with hydroxyurea, as measured by control of hematocrit and at least a 35% reduction in spleen volume (21% vs. 1%).

Data source: A phase III, international, open-label, randomized trial of 222 patients with polycythemia vera who had unacceptable side effects or did not respond adequately to hydroxyurea or standard therapy.

Disclosures: The study was sponsored by Incyte and Novartis. Four authors reported serving on the advisory board, serving as speakers or lecturers, and/or receiving grant support from Novartis; one author received grants from Incyte during the study; six are employees of Incyte or Novartis; and six authors had no disclosures.

FDA approves first generic version of Nexium

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The Food and Drug Administration approved the first generic formulation of esomeprazole magnesium delayed-release capsules, the agency announced Jan. 26.

The new generic formulation of Nexium is approved to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older, according to the FDA statement announcing the approval. Ivax Pharmaceuticals manufactures generic esomeprazole in 20-mg and 40-mg capsules.

Like Nexium, generic esomeprazole is also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prescriptions for generic esomeprazole will be dispensed with a medication guide, which provides patients with information about esomeprazole’s uses and risks, including diarrhea and bone fractures. Nexium prescriptions also come with a medication guide.

Ivax is a subsidiary of Teva Pharmaceuticals USA.

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The Food and Drug Administration approved the first generic formulation of esomeprazole magnesium delayed-release capsules, the agency announced Jan. 26.

The new generic formulation of Nexium is approved to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older, according to the FDA statement announcing the approval. Ivax Pharmaceuticals manufactures generic esomeprazole in 20-mg and 40-mg capsules.

Like Nexium, generic esomeprazole is also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prescriptions for generic esomeprazole will be dispensed with a medication guide, which provides patients with information about esomeprazole’s uses and risks, including diarrhea and bone fractures. Nexium prescriptions also come with a medication guide.

Ivax is a subsidiary of Teva Pharmaceuticals USA.

[email protected]

The Food and Drug Administration approved the first generic formulation of esomeprazole magnesium delayed-release capsules, the agency announced Jan. 26.

The new generic formulation of Nexium is approved to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older, according to the FDA statement announcing the approval. Ivax Pharmaceuticals manufactures generic esomeprazole in 20-mg and 40-mg capsules.

Like Nexium, generic esomeprazole is also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prescriptions for generic esomeprazole will be dispensed with a medication guide, which provides patients with information about esomeprazole’s uses and risks, including diarrhea and bone fractures. Nexium prescriptions also come with a medication guide.

Ivax is a subsidiary of Teva Pharmaceuticals USA.

[email protected]

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Updated HIV, HCV, HBV Blood Product Screening Test Approved

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Updated HIV, HCV, HBV Blood Product Screening Test Approved

An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay," according to the statement.

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An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay," according to the statement.

An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay," according to the statement.

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Updated HIV, HCV, HBV blood product screening test approved

An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay.,“ according to the statement.

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An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay.,“ according to the statement.

[email protected]

An updated version of a blood screening assay that detects human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donated blood has been approved by the Food and Drug Administration, the manufacturer, Roche, recently announced.

In a Jan. 9 press release, the company said that its “cobas TaqScreen MPX Test, v2.0” was approved for use “in the detection and identification” of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. The test “provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay.,“ according to the statement.

[email protected]

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Updated HIV, HCV, HBV blood product screening test approved
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Updated HIV, HCV, HBV blood product screening test approved
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