Novo Nordisk Secures U.S. Approval for Oral Weight-Loss Drug

The U.S. Food and Drug Administration has approved Novo Nordisk’s oral weight-loss pill, giving the drugmaker a crucial advantage in expanding beyond injectable treatments. The once-daily pill contains 25 milligrams of semaglutide, the same active ingredient used in Novo’s blockbuster injections Wegovy and Ozempic, and will be marketed under the Wegovy brand.

The approval comes at a pivotal time for Novo, which has faced a challenging year marked by share price declines, profit warnings, and intensifying competition from Eli Lilly. Slowing growth in injectable Wegovy sales and pressure from compounded versions have weighed on performance, making an effective oral alternative strategically important.

Clinical data underpinning the decision showed strong results. In a 64-week late-stage trial, patients taking oral semaglutide lost an average of 16.6% of body weight, compared with 2.7% for those on placebo. The drug was approved for chronic weight management in adults with obesity, or those who are overweight with at least one related health condition.

By offering a pill instead of an injection, Novo could significantly broaden access to treatment. Oral therapy may appeal to patients reluctant to use injectables and could ease adoption by insurers and employers grappling with rising obesity-related healthcare costs.

The approval positions Novo to tap into a vast and expanding market. The global obesity drug sector is projected to reach around $150 billion annually by the next decade, and the launch of an effective pill could unlock tens of millions of new patients, reinforcing Novo Nordisk’s role as a leading player in metabolic disease treatment.