FDA Approves First Daily Pill for Obesity, a Pill Form of Wegovy

The Food and Drug Administration on Monday approved a pill version of Novo Nordisk’s Wegovy, the first daily oral medication to treat obesity, CBS News and NBC News reported.

The tablet contains 25 milligrams of semaglutide, the same ingredient as injectable Wegovy and Ozempic, CBS News reported. In a Phase 3 trial, participants lost 13.6 percent of their body weight on average over about 15 months, compared with 2.2 percent for a placebo, CBS News reported; NBC News said those who followed the dosing schedule strictly lost more, an average of 16.6 percent over 64 weeks. Both outlets put injectable Wegovy at an average loss of about 15 percent. NBC News noted that comparisons with Eli Lilly’s drugs come from separate trials rather than head-to-head tests.

Novo Nordisk told NBC News it expects the pill to be widely available in January. CBS News reported that company officials said it would be on the market within weeks. The company has not released a list price, NBC News reported, though the pill is expected to cost less than weekly injections. Eli Lilly’s oral drug, orforglipron, is still under FDA review, giving Novo what CBS News called an edge in the race to market. NBC News said Lilly’s pill is expected to be approved in the coming months.

The pill arrives as demand for GLP-1 drugs, which mimic a natural hormone that controls appetite, has grown rapidly. CBS News and NBC News both reported that the lowest starting dose will cost $149 a month for some patients paying out of pocket, and NBC News said the price follows a deal with the Trump administration. The most common side effects of the drug class are gastrointestinal, such as nausea, according to both outlets, and NBC News said the pill must be taken first thing in the morning on an empty stomach with a small amount of water.

Insurance questions remain. NBC News reported that many private insurers restrict coverage of the injections because of their cost, and Medicare is barred by law from covering weight loss drugs. The pill was also approved to lower heart disease risk, which Medicare does cover, NBC News said.

Doctors quoted by the two outlets welcomed another option but did not call it a replacement. “It won’t replace injectables, but it broadens our tool kit in an important way,” said Dr. Christopher McGowan, a gastroenterologist, according to NBC News. Dr. Reshmi Srinath of the Mount Sinai Weight and Metabolism Management Program told CBS News that an oral option would help with access. Dr. Fatima Cody Stanford of Massachusetts General Hospital said the question should be about “having these options available to patients,” not who finishes first.