The U.S. Food and Drug Administration approved Novo Nordisk's weight-loss pill on Monday, giving the Danish drugmaker a leg up in the race to market a potent oral medication for shedding pounds as it looks to regain lost ground from rival Eli Lilly.
Shares of Novo Nordisk jumped 6.84% in extended trading on the news.
The pill is 25 milligrams of semaglutide, the same active ingredient in injectable Wegovy and Ozempic, and will be sold under the brand name Wegovy. Novo already sells an oral semaglutide for type 2 diabetes, Rybelsus.
The approval could help spur a turnaround for Novo after a rocky year of sliding shares, profit warnings and slowing sales of its injectable Wegovy amid intense competition from Lilly and pressure from compounded versions.
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.
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