The FDA approval, granted on Monday, covers a 25-milligram semaglutide pill, the same active ingredient used in Novo Nordisk’s injectable weight-loss and diabetes drugs Wegovy and Ozempic, News.Az reports, citing Reuters.
The oral medication will be marketed under the Wegovy brand. Novo already sells an oral form of semaglutide for type 2 diabetes under the name Rybelsus.
The approval is seen as a potential turning point for Novo Nordisk following a challenging year marked by falling share prices, profit warnings, and slowing sales of injectable Wegovy amid fierce competition from Eli Lilly and growing pressure from compounded alternatives.
Investor reaction was swift, with Novo Nordisk shares rising more than 7% in premarket trading on Tuesday.
A 64-week, late-stage study showed participants who took 25 mg of oral semaglutide once daily lost an average of 16.6% of their body weight, compared with 2.7% for those on a placebo.
The pill was approved for chronic weight management in adults with obesity or overweight and at least one related health condition, broadening the potential patient pool at a time when insurers, employers and governments are wrestling with spiraling healthcare costs related to obesity.
It could help open the door to tens of millions of untapped patients in a global market, forecast to be worth some $150 billion a year by next decade.
