The U.S. Food and Drug Administration has approved Foundayo, Eli Lilly’s once-daily oral GLP-1 weight-loss pill, marking the second such approval in the U.S. The drug is indicated for adults with obesity or those with overweight and weight-related medical conditions.
In clinical trials, patients on the highest dose lost an average of 27.3 pounds-nearly 12.5 times more than those on placebo. The FDA approved the drug in just 50 days, one of the fastest reviews on record.
Dosage begins at 0.8 mg, escalating monthly up to 17.2 mg based on tolerance. The monthly cost for uninsured patients is $149.
Common side effects include nausea, constipation, diarrhea, and fatigue. Eli Lilly warns Foundayo may cause thyroid tumors, including cancer. Prior studies link GLP-1 drugs to rare but serious risks: stomach paralysis, pancreatitis, bowel obstruction, and sudden vision loss.
The FDA mandates use alongside reduced-calorie diet and increased physical activity. Safety in children remains unestablished.