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Novo Nordisk (NVO) said the FDA has approved its weight-loss drug Wegovy for the reduction of major adverse cardiovascular events such as heart attack, stroke and death in overweight or obese people with established cardiovascular disease.
Wegovy, also known as semaglutide, is already approved for weight loss in the US. Novo Nordisk also markets semaglutide for diabetes under the brand name Ozempic.
Novo Nordisk said the label expansion was based on the company’s SELECT study, which showed Wegovy was able to reduce the risk of major adverse cardiovascular events by 20% versus placebo when added to standard-of-care.
The Danish drugmaker said it has also filed for a label expansion in the EU. A decision is expected this year.
Wegovy and Ozempic belong to a class of drugs called GLP-1s. Novo Nordisk’s main competitor in the GLP-1 drug market is Eli Lilly. (LLY)
Novo Nordisk shares have been on a tear in recent months, fueled by a positive news flow for Wegovy. The shares hit a new 52-week high of $138.28 on Thursday amid encouraging news for the company’s next-generation weight-loss drug candidate amycretin.
Late Thursday, Reuters reported that the company expects to get Wegovy approved in China later this year.
