FDA Approves Additional Indication for Wegovy

The FDA has approved an additional indication for Wegovy (semaglutide): to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.

The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy statistically significantly reduced the risk of MACE by 20% compared with placebo when added to standard of care. In the SELECT trial Wegovy 2.4 mg reduced the risk of major adverse cardiovascular events. The trial enrolled 17,604 adults aged 45 years or older with obesity and established cardiovascular disease with no prior history of diabetes. These results were released at the American Heart Association Scientific Session meeting in November 2023. The label for Wegovy has been updated to include data from SELECT.

Wegovy 2.4 mg, developed by Novo Nordisk, was approved first to treat obesity in adults. It has a list price of $1,349.02 per package, which is a 28-day supply. Novo Nordisk also markets a lower-dose version of semaglutide as Ozempic to treat patients with diabetes. It is available in 0.5 mg, 1.0 mg and 2.0 mg doses. The list price for Ozempic 1.0 mg is $935.77 for one pen.

This announcement comes just days after Novo Nordisk announced that Ozempic reduced kidney disease progression, major adverse cardiovascular events and death by 24%, according to topline results from the FLOW trial. The trial was stopped early on the recommendation from an independent data monitoring committee because an interim analysis found the study met the criteria for efficacy.