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Federal regulators have given the green light to Eli Lilly’s new weight-loss pill, marking the arrival of a second daily oral treatment option for obesity and related conditions.
On Wednesday, the Food and Drug Administration (FDA) granted expedited approval to orforglipron, a GLP-1 receptor agonist that mimics a natural hormone involved in appetite regulation and satiety. The medication will be marketed under the name Foundayo and is scheduled to begin shipping on Monday.
Eli Lilly has announced that insured patients may access the drug for as low as $25 per month using a company discount card, while out-of-pocket costs for uninsured users will range between $149 and $349 monthly, depending on dosage.
Foundayo joins Novo Nordisk’s oral Wegovy pill, which has seen more than 600,000 prescriptions in the U.S. since its approval last December. The FDA’s rapid 50-day review of Eli Lilly’s application was part of a new initiative to accelerate drug approval timelines.
In a clinical trial involving over 3,000 adults with obesity, participants receiving the highest dose of orforglipron (36 mg) lost an average of 11.2% of their body weight-approximately 25 pounds-over 16 months. This compares to a 2.1% weight loss among those given a placebo.
While these results are notable, they fall short of the weight loss achieved with Eli Lilly’s injectable Zepbound (21% average weight loss) and Novo Nordisk’s injectable Wegovy (around 15%).
Both oral pills offer the convenience of once-daily dosing. However, orforglipron, as a small-molecule GLP-1 drug, can be taken without timing restrictions, unlike the peptide-based Wegovy pill, which requires administration on an empty stomach followed by a 30-minute wait before eating or drinking.
Additional benefits observed in the orforglipron trial included reductions in waist circumference, blood pressure, triglycerides, and cholesterol levels.
Gastrointestinal side effects led to treatment discontinuation in 5% to 10% of participants on orforglipron, compared to nearly 3% in the placebo group.
According to a survey by the Kaiser Family Foundation, about one in eight Americans has used injectable GLP-1 drugs, though many face challenges with the high cost of these medications.
Eli Lilly’s oral pill will be part of a pricing agreement initiated during the previous administration aimed at reducing GLP-1 drug costs.
Following the FDA announcement, Eli Lilly’s stock rose more than 4% in afternoon trading.