New Weight-Loss Pill Receives Expedited Approval
Federal regulators have approved a new weight-loss medication, Foundayo, developed by Eli Lilly. This drug, known as orforglipron, has been recognized as the second daily oral medication for treating obesity and related conditions. As a GLP-1 medication, it mimics a natural hormone that helps control appetite and feelings of fullness. This is similar to injectable treatments that are widely used.
Shipments of Foundayo are scheduled to begin this Monday, marking a significant step in the availability of oral weight-loss options. For insured patients, the cost will range from $149 to $349 per month, depending on the dosage. This pill joins Novo Nordisk’s oral Wegovy, which has already seen over 600,000 prescriptions in the U.S. since its approval in December.
The Food and Drug Administration (FDA) granted approval as part of a new initiative aimed at reducing the time it takes to approve drugs. The agency reviewed Eli Lilly’s application in just 50 days, showcasing the efficiency of the process.
Clinical Trial Results
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% – about 25 pounds – over more than 16 months. This was significantly higher compared to the 2.1% weight loss observed in the placebo group, according to the New England Journal of Medicine.
While both the Lilly and Novo Nordisk pills showed results, they did not match the weight loss achieved by their injectable counterparts. Lilly’s Zepbound resulted in an average 21% weight loss, while Novo Nordisk’s injectable Wegovy achieved about 15%.
Convenience and Restrictions
Both once-daily pills offer convenience, but orforglipron stands out as a small-molecule GLP-1 drug that can be taken without restrictions. In contrast, Wegovy, a peptide, must be taken with a sip of water in the morning on an empty stomach, with a 30-minute wait before eating or drinking.
Participants using orforglipron also saw improvements in waist circumference, blood pressure, triglyceride levels, and cholesterol levels, as noted in the study.
Side Effects and Discontinuation Rates
Gastrointestinal issues were the most common side effects, leading between 5% and 10% of participants in the orforglipron study to discontinue treatment. This was higher compared to nearly 3% in the placebo group.
According to a survey by KFF, a nonprofit health policy research group, about 1 in 8 people in the U.S. have used injectable GLP-1 drugs. However, many face challenges in affording these costly shots.
The pill from Indianapolis-based Lilly will be included in a Trump administration deal aimed at lowering prices on GLP-1 drugs.
