FDA Clears Novo Nordisk’s Wegovy Weight-Loss Pill, Marking Major Shift in Obesity Drug Market

The U.S. Food and Drug Administration has approved Novo Nordisk’s oral weight-loss pill containing 25 milligrams of semaglutide, giving the Danish drugmaker a crucial first-mover advantage in the race to bring a potent obesity pill to market. The once-daily tablet, sold under the Wegovy brand, uses the same active ingredient as the company’s injectable Wegovy and Ozempic, and expands Novo’s oral portfolio beyond its diabetes drug Rybelsus.

The approval comes at a critical time for Novo, which has faced slowing sales of injectable Wegovy and rising competition from Eli Lilly. In a 64-week late-stage study, patients taking the oral semaglutide lost an average of 16.6% of their body weight, compared with 2.7% in the placebo group. Following the announcement, Novo’s U.S.-listed shares jumped 8%, while Lilly’s stock dipped about 1% in extended trading.

Approved for adults with obesity or overweight and at least one related health condition, the pill could significantly broaden access to weight-loss treatment, particularly among patients reluctant to use injections. Analysts estimate oral drugs could capture around 20% of the obesity market by 2030, part of a sector forecast to reach $150 billion annually. Novo said the starter dose will be available in early January, with U.S. manufacturing already underway, as the company looks to regain momentum in an increasingly competitive and rapidly expanding market.

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