Federal regulators have granted expedited approval to Eli Lilly's new weight-loss pill, Foundayo, marking it as the second daily oral medication for obesity and related health conditions in the United States. This authorisation comes under a new programme designed to significantly reduce drug approval timelines, with the FDA reviewing the application in just 50 days.
Key Details of Foundayo's Approval and Mechanism
The drug, known scientifically as orforglipron, functions as a GLP-1 medication. It mimics a natural hormone that regulates appetite and feelings of fullness, similar to widely used injectable treatments such as Zepbound and Wegovy. Shipments of Foundayo are scheduled to commence this Monday, providing a new option for patients seeking weight management solutions.
Pricing and Market Context
Eli Lilly has announced that insured patients can access Foundayo at a cost ranging from $149 to $349 per month, depending on the prescribed dosage. This positions the pill as a competitive alternative to Novo Nordisk's oral Wegovy, which has garnered over 600,000 prescriptions in the US since its approval in December. Both oral medications are part of a broader effort to expand affordable access to GLP-1 therapies, with Foundayo included in a Trump administration deal aimed at lowering prices for these drugs.
Clinical Trial Results and Efficacy
In a clinical trial involving more than 3,000 adults with obesity, participants who received the highest dose of orforglipron, 36 milligrams, experienced an average weight loss of 11.2% of their body weight over more than 16 months. This equates to approximately 25 pounds on average, compared to a 2.1% weight loss, or less than 5 pounds, in the placebo group, as reported in the New England Journal of Medicine.
However, both the Lilly and Novo Nordisk pills demonstrated less weight loss than their injectable counterparts. Lilly's injectable Zepbound achieves an average weight loss of 21%, while Novo Nordisk's injectable Wegovy averages about 15% weight reduction.
Convenience and Side Effects
Foundayo offers the convenience of a once-daily pill without dietary restrictions, as it is a small-molecule GLP-1 drug. In contrast, the Wegovy pill, a peptide, must be taken with a sip of water in the morning on an empty stomach, requiring a 30-minute wait before eating or drinking.
Beyond weight loss, users of orforglipron also showed improvements in waist circumference, blood pressure, triglyceride levels, and cholesterol levels. 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.
Broader Implications and Accessibility
According to a survey from KFF, a nonprofit health policy research group, about one in eight people in the US have used injectable GLP-1 drugs, but many struggle with the high costs. The introduction of Foundayo as an oral option may help address affordability and accessibility challenges, potentially expanding treatment options for obesity and related conditions in the healthcare market.
