FDA grants speedy approval to Eli Lilly’s weight-loss pill for obesity

Federal regulators on Wednesday approved Eli Lilly’s new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions.

The Food and Drug Administration granted expedited approval to orforglipron, a GLP-1 drug that works like widely used injectable medications to mimic a natural hormone that controls appetite and feelings of fullness.

The drug, which will be branded as Foundayo, is expected to begin shipping Monday. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Prices for people paying cash will range between $149 per month to $349 per month, depending on the dose.

The new pill joins drugmaker Novo Nordisk’s oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December.

The FDA authorized Eli Lilly’s drug as part of a new program aimed at cutting drug approval times. The agency said it reviewed the company’s application in 50 days.

In a clinical trial of more than 3,000 adults with obesity, participants who received the highest dose of orforglipron, 36 milligrams, lost 11.2% of their body weight –- about 25 pounds on average –- over more than 16 months. That compared with a 2.1% weight loss, or less than 5 pounds, in patients who received a placebo, or dummy pill, according to the New England Journal of Medicine.

Both the Lilly and Novo Nordisk pills resulted in less weight loss than the average achieved with Lilly’s injectable Zepbound, which results in a 21% average weight loss, or Novo Nordisk’s injectable Wegovy, which averages about 15%.

Both once-daily pills promise convenience, but orforglipron is a small-molecule GLP-1 drug that can be taken without restrictions. The Wegovy pill, a peptide, must be taken with a sip of water in the morning on an empty stomach, with a 30-minute wait before eating or drinking.

Users of orforglipron also saw improvements in waist circumference, blood pressure, triglyceride levels and cholesterol levels, the study found.

Side effects, mostly gastrointestinal issues, led between 5% and 10% of participants in the orforglipron study to discontinue treatment, compared with nearly 3% in the placebo group.

About 1 in 8 people in the U.S. have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more have trouble affording the costly shots.

The pill from Indianapolis-based Lilly will be included in a Trump administration deal to lower prices on GLP-1 drugs.

Shares of ELi Lilly and Company rose more than 4% in trading Wednesday afternoon.

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AP Health Writer Matthew Perrone contributed to this report.

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