The United States Food and Drug Administration has approved Novo Nordisk’s new weight-loss pill, marking a significant step for the Danish drugmaker as it seeks to strengthen its position in the increasingly competitive obesity treatment market.
The newly approved medication is a 25-milligram oral version of semaglutide, the same active ingredient used in Novo’s injectable drugs Wegovy and Ozempic. The pill will be marketed under the Wegovy brand, expanding the company’s weight-management portfolio beyond injections. Novo already sells an oral form of semaglutide for type 2 diabetes under the name Rybelsus.
The approval comes at a critical time for Novo Nordisk, following a challenging year marked by falling share prices, profit warnings and slowing sales of injectable Wegovy amid fierce competition from US rival Eli Lilly. Investors responded positively to the news, with Novo’s US-listed shares rising sharply in after-hours trading, while Lilly’s shares dipped.
Clinical trial data supported the FDA’s decision, with a 64-week late-stage study showing that adults who took the daily pill lost an average of 16.6 per cent of their body weight, compared with 2.7 per cent among those who received a placebo. The drug has been approved for chronic weight management in adults who are obese or overweight and have at least one related health condition.
Health experts say the pill could significantly widen access to treatment at a time when governments and insurers are grappling with rising healthcare costs linked to obesity. The global market for weight-loss drugs is projected to reach around $150 billion annually by the next decade, and oral medications are expected to play an increasingly important role.
Novo Nordisk is counting on the pill’s first-to-market advantage in the United States to regain momentum after losing ground to Lilly’s injectable drug Zepbound, which currently leads weekly prescription volumes. Lilly is also developing its own weight-loss pill, orforglipron, which could receive regulatory approval as early as next year.
According to Novo’s US leadership, a daily pill is likely to appeal to patients who are reluctant to use injections and could help boost uptake. The company has been manufacturing the drug in North Carolina and has built up supplies in anticipation of demand.
Analysts believe oral weight-loss drugs could account for about 20 per cent of the market by 2030, particularly among patients seeking simpler and less invasive treatment options. While injections are expected to remain popular, pills offer practical advantages such as ease of travel and no requirement for refrigeration.
Novo said the starter dose of the Wegovy pill would become available early next year. Pricing arrangements include discounted starter doses for US government health programmes and selected direct-to-consumer channels.
