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The lipoglycopeptide antibiotic telavancin has been approved for treating patients with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Staphylococcus aureus, the Food and Drug Administration announced.
Telavancin, marketed as Vibativ by Theravance, "should be used for the treatment of HABP/VABP only when alternative treatments are not suitable," the FDA said in a June 21 statement announcing the approval. It is not approved to treat other bacteria that cause pneumonia, the statement pointed out. It is administered once a day.
Approval of the expanded indication was based on the safety and effectiveness of telavancin in two studies of 1,532 patients with HABP/VABP, which compared treatment with telavancin to vancomycin, according to the FDA.
In a statement, the manufacturer said that, in the two noninferiority studies, ATTAIN I and ATTAIN II, patients received either telavancin (10 mg/kg IV once a day) or vancomycin (1 g IV every 12 hours).
All-cause mortality 28 days after treatment started was comparable between the two groups, but among those patients with pre-existing kidney disease, mortality was higher for those taking telavancin – information that is now included in the boxed warning for telavancin, according to the FDA. The most common adverse effect associated with treatment in the trials was diarrhea.
Telavancin should be considered for patients with pre-existing moderate to severe renal impairment (creatinine clearance of 50 mL/min or less) "only when the anticipated benefit to the patient outweighs the potential risk," according to Theravance.
Telavancin was initially approved in 2009 as a treatment for complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria, including both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains of S. aureus, with a boxed warning about the fetal risks of treatment.
In a statement, the company said that telavancin would be made available to wholesalers for purchase for the pneumonia indication in the third quarter of 2013.
The lipoglycopeptide antibiotic telavancin has been approved for treating patients with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Staphylococcus aureus, the Food and Drug Administration announced.
Telavancin, marketed as Vibativ by Theravance, "should be used for the treatment of HABP/VABP only when alternative treatments are not suitable," the FDA said in a June 21 statement announcing the approval. It is not approved to treat other bacteria that cause pneumonia, the statement pointed out. It is administered once a day.
Approval of the expanded indication was based on the safety and effectiveness of telavancin in two studies of 1,532 patients with HABP/VABP, which compared treatment with telavancin to vancomycin, according to the FDA.
In a statement, the manufacturer said that, in the two noninferiority studies, ATTAIN I and ATTAIN II, patients received either telavancin (10 mg/kg IV once a day) or vancomycin (1 g IV every 12 hours).
All-cause mortality 28 days after treatment started was comparable between the two groups, but among those patients with pre-existing kidney disease, mortality was higher for those taking telavancin – information that is now included in the boxed warning for telavancin, according to the FDA. The most common adverse effect associated with treatment in the trials was diarrhea.
Telavancin should be considered for patients with pre-existing moderate to severe renal impairment (creatinine clearance of 50 mL/min or less) "only when the anticipated benefit to the patient outweighs the potential risk," according to Theravance.
Telavancin was initially approved in 2009 as a treatment for complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria, including both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains of S. aureus, with a boxed warning about the fetal risks of treatment.
In a statement, the company said that telavancin would be made available to wholesalers for purchase for the pneumonia indication in the third quarter of 2013.
The lipoglycopeptide antibiotic telavancin has been approved for treating patients with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Staphylococcus aureus, the Food and Drug Administration announced.
Telavancin, marketed as Vibativ by Theravance, "should be used for the treatment of HABP/VABP only when alternative treatments are not suitable," the FDA said in a June 21 statement announcing the approval. It is not approved to treat other bacteria that cause pneumonia, the statement pointed out. It is administered once a day.
Approval of the expanded indication was based on the safety and effectiveness of telavancin in two studies of 1,532 patients with HABP/VABP, which compared treatment with telavancin to vancomycin, according to the FDA.
In a statement, the manufacturer said that, in the two noninferiority studies, ATTAIN I and ATTAIN II, patients received either telavancin (10 mg/kg IV once a day) or vancomycin (1 g IV every 12 hours).
All-cause mortality 28 days after treatment started was comparable between the two groups, but among those patients with pre-existing kidney disease, mortality was higher for those taking telavancin – information that is now included in the boxed warning for telavancin, according to the FDA. The most common adverse effect associated with treatment in the trials was diarrhea.
Telavancin should be considered for patients with pre-existing moderate to severe renal impairment (creatinine clearance of 50 mL/min or less) "only when the anticipated benefit to the patient outweighs the potential risk," according to Theravance.
Telavancin was initially approved in 2009 as a treatment for complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria, including both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains of S. aureus, with a boxed warning about the fetal risks of treatment.
In a statement, the company said that telavancin would be made available to wholesalers for purchase for the pneumonia indication in the third quarter of 2013.
