An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug.
Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece.
While one member of the FDA’s endocrinologic and metabolic drugs advisory committee abstained from voting, the other members voted 16-0 to approve the drug as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes.
Nordisk shares rose earlier this year after the company reported that semaglutide succeeded in lowering glucose levels in a late-stage trial.
The 40-week trial enrolled 1,200 patients and evaluated two dosages of semaglutide in combination with a standard-of-care-drug. The study compared its drug against Eli Lilly‘s (NYSE:LLY) dulaglutide compound.
Nordisk reported that semaglutide was statistically significant in lowering glucose levels and body weight in patients with Type II diabetes compared to dulaglutide.
The company also noted that the number of patients reporting cases of diabetic retinopathy was low and comparable in both treatment arms.
Semaglutide and Eli Lilly’s dulglutide are both GLP-1 analogues – drugs that trigger the production of insulin, while lessening appetite and food intake. Lilly’s Trulicity product has been a primary growth driver for the drugmaker, but analysts have suggested that Nordisk’s semaglutide could represent competition.
“While we project that Lilly will retain its leadership position in the once-weekly segment, Novo has made headway with its oral formulation that could potentially shift the market dynamics in its favor over the longer term,” Barclays analysts said, according to Reuters.
