FDA Accelerates Approval for Eli Lilly's Oral Obesity Medication Foundayo
Federal health regulators have granted expedited approval to a new weight-loss pill developed by pharmaceutical giant Eli Lilly, marking a significant advancement in oral treatments for obesity and related conditions. The Food and Drug Administration (FDA) authorised the drug, branded as Foundayo, on Wednesday as part of a programme designed to slash drug approval timelines.
Expedited Review and Clinical Trial Results
The FDA reviewed Eli Lilly's application for orforglipron, the active ingredient in Foundayo, in just 50 days. This swift approval process underscores the agency's commitment to accelerating access to innovative therapies. In a clinical trial involving over 3,000 adults with obesity, participants receiving the highest dose of 36 milligrams lost an average of 11.2% of their body weight over more than 16 months. This equates to approximately 25 pounds, compared to a mere 2.1% weight loss, or less than 5 pounds, in the placebo group, as reported by the New England Journal of Medicine.
Comparison with Existing Treatments
Foundayo joins Novo Nordisk's oral Wegovy pill, which has garnered more than 600,000 prescriptions in the United States since its approval in December. Both once-daily pills offer greater convenience than injectable alternatives, but orforglipron, a small-molecule GLP-1 drug, can be taken without dietary restrictions. In contrast, the peptide-based Wegovy pill must be consumed with a sip of water on an empty stomach in the morning, followed by a 30-minute wait before eating or drinking.
However, both oral medications result in less weight loss than their injectable counterparts. Eli Lilly's injectable Zepbound achieves an average weight loss of 21%, while Novo Nordisk's injectable Wegovy averages about 15%. Despite this, Foundayo demonstrated additional health benefits, including improvements in waist circumference, blood pressure, triglyceride levels, and cholesterol levels.
Pricing, Availability, and Side Effects
Eli Lilly anticipates that Foundayo will begin shipping on Monday. The company has announced that insured patients may access the drug for as low as $25 per month using a Lilly discount card. For those paying out-of-pocket, prices will range from $149 to $349 monthly, depending on the dosage. This pricing structure aims to address affordability concerns, as a survey by the nonprofit health policy research group KFF indicates that while one in eight Americans has used injectable GLP-1 drugs, many struggle with the high costs.
Side effects were primarily gastrointestinal issues, leading between 5% and 10% of participants in the orforglipron study to discontinue treatment, compared to nearly 3% in the placebo group. The pill from Indianapolis-based Eli Lilly will be included in a Trump administration initiative to reduce prices for GLP-1 medications, potentially enhancing accessibility for a broader patient population.
