Novo Nordisk (NYSE:NVO) said Thursday that its blockbuster weight-loss drug Wegovy could receive expanded approval from the U.S. Food and Drug Administration within six months.
Chief Financial Officer Karsten Munk Knudsen told the media that the Danish pharmaceutical company had received priority review in its application for approval of Wegovy as a treatment for reducing the risk of cardiovascular disease.
A greenlight from the health agency could potentially boost the insurance coverage prospects of the highly sought-after drug.
Earlier Thursday, Novo Nordisk in its third-quarter earnings announced plans to get expanded approval from the FDA, but shared no timeline. It also reported record profits and sales for the period on the back of the runaway success of its obesity drug.
Late-stage trial data in August showed that Wegovy reduced the risk of major cardiovascular events such as heart attacks or strokes by 20%, compared with a placebo.
“The SELECT study is, in an obese population with established cardiovascular disease, does Wegovy reduce cardiovascular risk? And the answer is, yes it does, by 20%,” Knudsen said Thursday.
The results of the closely watched “SELECT” trial were seen as a boon for Novo Nordisk’s ambitions of moving beyond Wegovy’s image as a “vanity drug.”
The findings provided an added boost for the company’s stock, which has been on the up this year. Shares were higher $4.25, or 4.4%, Thursday morning to $101.91 following its earnings report; over the year to date, shares are almost 45% higher.
