FDA approves Eli Lilly’s oral GLP-1 weight-loss pill for obesity

Body

Federal regulators approved Eli Lilly’s once-daily oral GLP-1 medication orforglipron to treat obesity and other weight-related conditions, marking a second daily pill option in a drug class dominated by injectable therapies. The U.S. Food and Drug Administration granted expedited approval to the drug, according to a Wednesday statement and FDA action described by the company.

Lilly said the oral medicine will be branded as Foundayo and is expected to begin shipping Monday. The company also said people with insurance may be able to start receiving the drug at $25 per month with a Lilly discount card, while cash prices for those not using insurance would range from $149 to $349 per month depending on the dose.

The FDA authorized the approval under a program aimed at reducing drug review timelines. The agency said it reviewed Lilly’s application in 50 days, and the expedited pathway is intended to speed access to certain therapies.

Orforglipron is designed to work like widely used injectable GLP-1 medications by mimicking a natural hormone involved in controlling appetite and the feeling of fullness. In contrast with peptide-based oral options that require specific administration instructions, Lilly’s oral small-molecule GLP-1 pill can be taken without restrictions, the company said.

In the trial cited by Lilly and reported by The Associated Press, more than 3,000 adults with obesity participated. Participants receiving the highest tested dose of orforglipron, 36 milligrams, lost 11.2% of their body weight—about 25 pounds on average—over more than 16 months, compared with a 2.1% weight loss in the placebo group, according to results published in the New England Journal of Medicine.

The reported trial comparisons also placed the oral pill’s results alongside established injectable GLP-1 therapies. Both Lilly’s oral orforglipron and Novo Nordisk’s oral Wegovy pill resulted in less weight loss than the average achieved with Lilly’s injectable Zepbound and Novo Nordisk’s injectable Wegovy, with the report citing an average 21% loss for Zepbound and about 15% for injectable Wegovy.

In addition to weight reduction, Lilly reported that participants in the orforglipron study saw improvements in waist circumference, blood pressure, triglyceride levels and cholesterol levels. The study also reported that side effects—mostly gastrointestinal—led between 5% and 10% of participants receiving orforglipron to discontinue treatment, compared with nearly 3% in the placebo group.

The approval arrives as GLP-1 use expands in the United States, but access remains a concern for many patients. The report cited a survey from KFF, a nonprofit health policy research group, saying about 1 in 8 people in the U.S. have used injectable GLP-1 drugs, and that many people face difficulty affording the shots.

Lilly said the Foundayo pill will be included in a Trump administration deal aimed at lowering prices on GLP-1 drugs. Shares of Eli Lilly and Company rose more than 4% in Wednesday trading, according to the report.