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FDA review supports safety, efficacy claims for semaglutide
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A preliminary review by the FDA states that the GLP-1 receptor agonist semaglutide is safe and effective for the indication of improving glycemic control in adults with type 2 diabetes, according to a briefing document released by the agency this week.
Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet Wednesday to discuss the safety and efficacy of a new drug application for semaglutide (Novo Nordisk) as an adjunct to diet and exercise to improve glycemic control, following overall positive results from the SUSTAIN clinical trial program, which included more than 8,000 adults with type 2 diabetes.
In the SUSTAIN program, once-weekly semaglutide was studied in combination with oral-antidiabetic agents and in combination with basal insulin. When compared with sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo, semaglutide demonstrated sustained blood glucose control
The cardiovascular outcomes trial SUSTAIN 6 demonstrated a reduction in CV risk compared with placebo, as an add-on to standard of care in patients with established CVD.
Advisory committee members will consider several draft points relating to efficacy and safety endpoints, including a potential increase in the risk for complications related to diabetic retinopathy observed in the SUSTAIN-6 trial. In an FDA ophthalmology consult outlined in the briefing documents, reviewers noted that, based on the data, there is “no reason to restrict semaglutide with respect to population or dosing schedule,” adding that there is no reason to require more ophthalmic follow-up.
“Both doses of semaglutide (0.5 mg and 1.0 mg) demonstrated superiority to placebo, in terms of change in HbA1c from baseline, in a monotherapy trial as well as in a trial with basal insulin background therapy,” the FDA wrote in the briefing document. “Both doses of semaglutide also demonstrated superiority to active comparators sitagliptin and insulin glargine for the HbA1c primary endpoint. Semaglutide 1.0 mg also demonstrated superiority to exenatide ER.”
The observed treatment effect for the primary endpoint was also consistent across subgroups, according to the FDA.
“In all the key efficacy trials, both doses of semaglutide also demonstrated superiority to placebo and the active comparators in terms of change in body weight from baseline,” the document states. “In the CVOT, both doses of semaglutide demonstrated superiority to placebo in terms of change in HbA1c and body weight at Week 104 as well as change in HbA1c at Week 30 for subjects on premix insulin at baseline and for subjects on [sulfonylurea] monotherapy at baseline, although change in HbA1c at Week 104 was not a prespecified secondary endpoint.”
In addition to trial data reviews and clinical perspectives, the meeting will include presentations from the NIH, Novo Nordisk and the FDA reviewing risk factors associated with diabetic retinopathy and an open public hearing, followed by committee deliberation, discussion and voting. The advisory panel’s recommendations are nonbinding, although the FDA often follows its suggestions. – by Regina Schaffer
For more information:
Novo Nordisk Briefing Information