FDA Backs First Obesity Pill, Boosting Ozempic-Style Treatment Market
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Washington D.C.: US regulators have approved the first daily oral medication to treat obesity, marking a major breakthrough for Novo Nordisk and the rapidly expanding market for GLP-1 weight-loss drugs. The US Food and Drug Administration (FDA) has cleared a pill version of Wegovy, making it the first oral treatment approved specifically for obesity.
The decision gives Danish drug-maker Novo Nordisk a lead over rival Eli Lilly, whose oral GLP-1 drug, orforglipron, is still under FDA review.
The newly approved Wegovy pill contains 25 milligrams of semaglutide — the same active ingredient used in Novo Nordisk’s injectable Wegovy and diabetes drug Ozempic. Like Ozempic and other GLP-1 medicines, the pill works by mimicking a natural hormone that suppresses appetite and increases feelings of fullness.
Novo Nordisk said the oral Wegovy is expected to be available in the US within weeks. Experts believe the pill format could widen access to obesity treatment by offering an alternative to injections and potentially lowering costs, as pills are generally cheaper to manufacture.
The FDA approval comes as Ozempic-style drugs face heightened regulatory scrutiny. Medicines regulators have recently issued warnings about a possible risk of suicidal thoughts and behaviours linked to GLP-1 drugs, alongside known side effects such as nausea and diarrhoea.
Despite these concerns, demand for GLP-1 medications continues to surge. Injectable drugs such as Wegovy and Ozempic have transformed obesity and diabetes care in recent years, particularly in the US, where around 100 million people are living with obesity.
Earlier this year, the Trump administration said it had negotiated lower prices with drug manufacturers for GLP-1 medicines, which can cost more than $US1,000 a month. Under an agreement reached in November, Novo Nordisk and Eli Lilly committed to selling starter doses of their weight-loss pills, if approved, for $US149 a month to Medicare and Medicaid patients and uninsured cash-paying customers.
With the FDA’s latest approval, Novo Nordisk has strengthened its position in the booming obesity drug market, even as Ozempic-style treatments remain under close regulatory watch.
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