on PinterestThe FDA has approved a new once-daily GLP-1 pill for weight loss.
on PinterestThe FDA has approved a new once-daily GLP-1 pill for weight loss. Image Credit: Healthline/Photo by Eli Lilly
- Federal regulators have approved the GLP-1 tablet Foundayo for use in weight management.
- Experts say having another weight loss medication in pill form could help people stick to a weight management regimen.
- They add that any weight loss medication regimen should be used in conjunction with a healthy diet and regular exercise.
Federal regulators have given the green light to a new GLP-1 weight loss tablet that people can take with or without food.
Officials at the Food and Drug Administration (FDA) have issued fast-track approval to orforglipron, a “molecular entity” pill manufactured by Eli Lilly and sold under the brand name Foundayo.
Foundayo was approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight with at least one weight-related comorbid condition.
Foundayo is now the second GLP-1 medication to be approved in pill form. A tablet form of the semaglutide-based drug Wegovy was given the go-ahead in January.
Foundayo is an oral GLP-1 receptor agonist taken once daily. The starting dosage is 0.8 milligrams (mg), increased to 2.5 mg after at least 30 days, and then to 5.5 mg after another 30 days. The dosage may be increased to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability, according to the FDA.
Eli Lilly officials said Foundayo will be available via LillyDirect with prescriptions accepted immediately and shipping beginning April 6. Broad availability through U.S. retail pharmacies and telehealth providers is expected soon.
Company officials added that eligible people with commercial insurance may pay as little as $25 per month for the drug. Individuals opting for self-pay can purchase Foundayo for $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as early as July 1.
Experts say the approval is a positive step toward managing obesity.
“It’s a significant milestone to have another GLP-1 tablet,” said Pouya Shafipour, MD, a family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA.
Zhaoping Li, MD, the chief of the Division of Clinical Nutrition at UCLA Health and director of the UCLA Center for Human Nutrition in Los Angeles, also welcomed the news. “It is great to have new tools added to our toolbox to deal with obesity,” she told Healthline.
Fast approval for weight loss pill Foundayo
The Foundayo approval was conducted under the FDA’s National Priority Voucher pilot program, which is designed to expedite the approval of medications needed to address national health priorities. The Foundayo application was approved 50 days after submission.
The approval followed two randomized, double-blind, placebo-controlled trials in adults who have obesity or overweight with one or more weight-related comorbidities. The trials lasted for 72 days.
Eli Lilly officials said that in the ATTAIN-1 trial, individuals taking the highest dose of Foundayo who
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