FDA Approval and Launch
The Food and Drug Administration approved Eli Lilly's once-daily weight-loss pill, Foundayo, on Wednesday. The drug manufacturer announced that shipments of Foundayo would begin as soon as Monday. Foundayo is the second oral GLP-1 medication to reach the market, following Novo Nordisk's Wegovy pill approval in December.
Pricing and Accessibility
The starting dose of Foundayo is projected to cost about $149 per month for individuals paying without insurance. Higher doses could cost as much as $349 a month. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Under a proposal from the Trump administration, Medicare could begin covering the drug for some patients this summer, with copays as low as $50 a month.
Pill vs. Injection
According to PBS NewsHour citing the New England Journal of Medicine, participants receiving the highest dose of orforglipron (36 milligrams) lost 11.2% of their body weight—about 25 pounds on average—over more than 16 months. This is less than injectable versions of Wegovy and Zepbound, which average about 15% and 21% weight loss, respectively. Eli Lilly CEO Dave Ricks acknowledged that Zepbound is more effective, but said pills still have a place.
Patient Experiences
Maggie Linton, 77, participated in the clinical trial for Foundayo and lost nearly 60 pounds. Linton also saw improvements in her blood pressure and cholesterol. Once the trial ended, she gained 10 pounds back but was able to keep off most of the weight loss by being active.
Competitive Landscape
Novo Nordisk Executive Vice President for US Operations Jamey Millar discussed the US approval of Eli Lilly's obesity pill and the expansion of the GLP-1 category. The FDA reviewed Eli Lilly's application in 50 days, as part of a new program aimed at cutting drug approval times. The new pill joins Novo Nordisk's oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December.
Dosing and Side Effects
Foundayo will be offered in six doses, with patients typically starting on the lowest dose and working their way up to reduce side effects. It can be taken at any time of day without meal restrictions. Side effects of Foundayo were similar to its injectable drugs, with gastrointestinal issues being the most commonly reported. Between 5% and 10% of participants in the orforglipron study discontinued treatment due to side effects, compared with nearly 3% in the placebo group.
Market Impact
Eli Lilly's shares rose more than 4% in trading Wednesday afternoon.
