US regulators have approved Novo Nordisk's weight-loss pill, giving the Danish drugmaker a major boost in the fast-growing obesity treatment market and an edge over rival Eli Lilly.
The US Food and Drug Administration on Monday cleared a daily oral version of Wegovy containing 25 milligrams of semaglutide, the same active ingredient used in Novo's injectable Wegovy and Ozempic. It is the first pill approved in the US specifically to treat obesity.
First oral treatment for obesity in the United States
The approval comes as Novo looks to regain market share after losing ground to Eli Lilly's injectable drug Zepbound. Investors welcomed the news, sending Novo's US-listed shares up about 8% in extended trading.
In a late-stage clinical trial, patients taking the pill lost an average of 16.6% of their body weight over 64 weeks, compared with 2.7% for those on a placebo. The drug was approved for adults with obesity or overweight who also have at least one related health condition.
Appealing to patients reluctant to use injections
Novo said the pill could significantly expand access to treatment by appealing to patients reluctant to use injections. Analysts estimate oral weight-loss drugs could make up around 20% of the market by 2030.
The company plans to launch the pill in early January, with manufacturing based in the United States. Eli Lilly's competing weight-loss pill, orforglipron, could receive FDA approval as early as next spring.
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