FDA panel advises approval of semaglutide to lower HbA1c in patients with type 2 diabetes

 

The Food and drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the approval of a once-weekly semaglutide injection for adults with type 2 diabetes mellitus. The vote was 16-0 in favor of approval, with one committee member abstaining.

The committee met on Oct. 18 and discussed the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection when used to help glycemic control in addition to diet and exercise. Semaglutide, manufactured and submitted for approval by Novo Nordisk, is described by the company as “an investigational analog of native human glucagonlike peptide–1,” with a half-life of approximately 1 week, making the agent appropriate for weekly dosing.

The committee based its approval recommendation mainly on data from a global phase 3 clinical trial program known as SUSTAIN (clinical trial number NCT01720446) that included evaluations of cardiovascular outcomes, safety, and efficacy in adults with type 2 diabetes, including some with renal disease and increased cardiovascular risk.

The researchers found some increase in diabetic retinopathy in the SUSTAIN trials, but a post-hoc analysis found that “To the extent that the data suggest a signal that there was progression of diabetic retinopathy in patients with significant decreases in HbA_1c, these events should be expected because they are consistent with treatments that decrease HbA_1c. While this decrease may result in an initial increase in retinopathy, ocular health is ultimately benefited by decreasing HbA_1c.”

Novo Nordisk submitted the application for semaglutide in December 2016; the drug also is being reviewed in Europe and Japan.

The FDA is not obligated to follow the committee’s recommendation but considers it as part of the review process of new drug applications.  

 

The Food and drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the approval of a once-weekly semaglutide injection for adults with type 2 diabetes mellitus. The vote was 16-0 in favor of approval, with one committee member abstaining.

The committee met on Oct. 18 and discussed the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection when used to help glycemic control in addition to diet and exercise. Semaglutide, manufactured and submitted for approval by Novo Nordisk, is described by the company as “an investigational analog of native human glucagonlike peptide–1,” with a half-life of approximately 1 week, making the agent appropriate for weekly dosing.

The committee based its approval recommendation mainly on data from a global phase 3 clinical trial program known as SUSTAIN (clinical trial number NCT01720446) that included evaluations of cardiovascular outcomes, safety, and efficacy in adults with type 2 diabetes, including some with renal disease and increased cardiovascular risk.

The researchers found some increase in diabetic retinopathy in the SUSTAIN trials, but a post-hoc analysis found that “To the extent that the data suggest a signal that there was progression of diabetic retinopathy in patients with significant decreases in HbA_1c, these events should be expected because they are consistent with treatments that decrease HbA_1c. While this decrease may result in an initial increase in retinopathy, ocular health is ultimately benefited by decreasing HbA_1c.”

Novo Nordisk submitted the application for semaglutide in December 2016; the drug also is being reviewed in Europe and Japan.

The FDA is not obligated to follow the committee’s recommendation but considers it as part of the review process of new drug applications.  

 

The Food and drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the approval of a once-weekly semaglutide injection for adults with type 2 diabetes mellitus. The vote was 16-0 in favor of approval, with one committee member abstaining.

The committee met on Oct. 18 and discussed the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection when used to help glycemic control in addition to diet and exercise. Semaglutide, manufactured and submitted for approval by Novo Nordisk, is described by the company as “an investigational analog of native human glucagonlike peptide–1,” with a half-life of approximately 1 week, making the agent appropriate for weekly dosing.

The committee based its approval recommendation mainly on data from a global phase 3 clinical trial program known as SUSTAIN (clinical trial number NCT01720446) that included evaluations of cardiovascular outcomes, safety, and efficacy in adults with type 2 diabetes, including some with renal disease and increased cardiovascular risk.

The researchers found some increase in diabetic retinopathy in the SUSTAIN trials, but a post-hoc analysis found that “To the extent that the data suggest a signal that there was progression of diabetic retinopathy in patients with significant decreases in HbA_1c, these events should be expected because they are consistent with treatments that decrease HbA_1c. While this decrease may result in an initial increase in retinopathy, ocular health is ultimately benefited by decreasing HbA_1c.”

Novo Nordisk submitted the application for semaglutide in December 2016; the drug also is being reviewed in Europe and Japan.

The FDA is not obligated to follow the committee’s recommendation but considers it as part of the review process of new drug applications.