FDA Approves Foundayo: New Once-Daily GLP-1 Pill for Weight Loss with Fast-Track Approval

The U.S. Food and Drug Administration (FDA) has granted fast-track approval to Foundayo, a once-daily GLP-1 pill for weight loss developed by Eli Lilly and marketed under the brand name orforglipron.

Foundayo is approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and support long-term weight reduction in adults with obesity or overweight conditions who have at least one weight-related comorbid condition.

This approval makes Foundayo the second GLP-1 medication available in pill form, following the January approval of a semaglutide-based Wegovy tablet.

Dosage and Administration

Foundayo is an oral GLP-1 receptor agonist taken once daily. The recommended dosage schedule is as follows:

• Starting dose: 0.8 milligrams (mg) for at least 30 days
• Second dose: 2.5 mg for at least 30 days
• Third dose: 5.5 mg for at least 30 days
• Optional increases: Up to 9 mg, 14.5 mg, or 17.2 mg, based on treatment response and tolerability, with each increase requiring at least 30 days at the prior dose

Availability and Cost

Eli Lilly officials announced that Foundayo will be available via LillyDirect with prescriptions accepted immediately and shipping beginning April 6. Broader availability through U.S. retail pharmacies and telehealth providers is expected in the near future.

Cost details include:

• Commercial insurance: As low as $25 per month for eligible individuals
• Self-pay: $149 per month for the lowest dose
• Medicare Part D: As low as $50 per month for eligible individuals, with availability expected as early as July 1

Safety and Regulatory Review

Despite the approval, the FDA has instructed Eli Lilly to conduct further studies on potential risks associated with Foundayo, including heart, liver, and other safety concerns. The approval was granted under the FDA’s National Priority Voucher pilot program, which expedites medications addressing national health priorities.

The Foundayo application was approved 50 days after submission, following two randomized clinical trials involving over 3,000 participants. The trials evaluated the medication’s efficacy and safety over 72 weeks.

Expert Reactions

“It’s a significant milestone to have another GLP-1 tablet.”

“It is great to have new tools added to our toolbox to deal with obesity.”

Experts emphasize that weight loss medications like Foundayo should be used as part of a comprehensive approach that includes a healthy diet and regular exercise.