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In a significant development for those battling weight-related issues, federal regulators have given the green light to a new weight-loss pill from Eli Lilly. This new medication marks the second daily oral treatment approved for addressing obesity and similar conditions.
The Food and Drug Administration (FDA) has expedited the approval of orforglipron, a GLP-1 drug that emulates a natural hormone responsible for regulating appetite and promoting a sense of fullness, much like the popular injectable treatments currently available.
Marketed under the name Foundayo, the drug is set to start shipping on Monday. Eli Lilly announced that individuals with insurance coverage might access Foundayo for as little as $25 per month with a Lilly discount card. For those without insurance, the monthly cost will vary between $149 and $349, contingent on the dosage.
Foundayo enters the market alongside Novo Nordisk’s oral Wegovy pill, which has seen over 600,000 prescriptions in the U.S. since its approval last December. This addition reflects the growing demand and reliance on oral weight-loss medications.
The approval of Eli Lilly’s drug was facilitated by a new FDA initiative designed to expedite drug approval processes. Impressively, the agency reviewed and approved the application in a mere 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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