FDA approves Wegovy weight loss pill from Novo Nordisk

The Food and Drug Administration on Monday approved a pill version of Wegovy, Novo Nordisk’s blockbuster weight loss drug. The Wegovy pill, as it’s called, is first oral version of a GLP-1 drug that has been brought to market for weight loss. A second pill, from Eli Lilly, is also expected to be approved in the coming months. GLP-1 drugs - which include semaglutide, the drug in Novo Nordisk’s Ozempic and Wegovy, and tirzepatide, the drug in Lilly’s Mounjaro and Zepbound - have soared in popularity in recent years. The compounds, initially approved for diabetes, can also offer significant weight loss. The drugs all come in an injectable form. (Novo Nordisk does make one pill version of semaglutide, called Rybelsus, for diabetes. It comes in a lower dose than the new version for weight loss.) “This is a meaningful step forward in the field,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina. “It won’t replace injectables, but it broadens our tool kit in an important way.” “Pills are familiar, nonintimidating and fit more naturally into most people’s routines,” McGowan added. “For many patients, a pill isn’t just easier, it’s psychologically more acceptable.” Novo Nordisk hasn’t released the list price for the pill, which must be taken daily, but it’s expected to be cheaper than the weekly injections. Questions remain over insurance coverage; many private insurers restrict coverage of the injections because of their high cost. Medicare, by law, is barred from covering weight loss drugs, but the pill was also approved for lowering heart disease risk - which Medicare does cover. In November, Novo Nordisk reached a deal with the Trump administration to sell the lowest dose of the pill for $149 a month for people who pay out of pocket, in exchange for tariff relief. Lilly made a similar agreement for its weight loss pill. Like the injections, the pill will come in several doses. People typically start at the lowest dose and gradually increase over several weeks to adjust to any side effects. How well does the Wegovy pill work? Phase 3 clinical trial results published in the New England Journal of Medicine found that people who took the highest dose of the Wegovy pill lost 16.6% of their body weight, on average, after 64 weeks, compared with 2.2% weight loss in the placebo group. That’s roughly on par with the injectable version of Wegovy, which was shown in clinical trials to reduce weight by about 15% after 68 weeks. Dr. Shauna Levy, medical director of the Tulane Weight Loss Center, said that the biggest challenge for people who opt for the pill version will most likely be adherence: The pill must be taken first thing in the morning, on an empty stomach, with no more than 4 ounces of water. People in the clinical trial who didn’t stick to the strict schedule lost less weight, 13.6% of their body weight on average. The open question is “real-world performance,” McGowan...

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