Lilly's New Weight-Loss Pill Foundayo Approved by FDA

The FDA approved Eli Lilly's once-daily weight-loss pill Foundayo, making it the second oral GLP-1 pill on the U.S. market. In trials, the highest dose produced about a 12% average weight loss after 72 weeks.

The U.S. Food and Drug Administration has approved Eli Lilly's once-daily weight-loss pill, sold as Foundayo (orforglipron). The approval follows the recent launch of Novo Nordisk's Wegovy pill and adds a second oral GLP-1 option for people seeking non-injectable treatments. Clinical trials of Foundayo showed average weight loss at the highest dose of about 12% after 72 weeks. The pill can be taken at any time of day, with or without food, a difference Lilly emphasizes compared with the Wegovy pill. Side effects reported were mainly gastrointestinal. Coverage and wider rollout are still being determined. Key facts: - The FDA approved Foundayo (orforglipron) as a once-daily oral weight-loss medication. - In Lilly's trials, the highest dose yielded about 12.4% average weight loss after 72 weeks. - The Wegovy pill previously reported about 16.6% average weight loss in a 64-week trial and launched earlier. - Foundayo can be taken with or without food and at any time of day, unlike the Wegovy pill which must be taken on an empty stomach in the morning. - The most commonly reported side effects were gastrointestinal, such as nausea and diarrhea. - The lowest starting dose was priced at about $149 a month for cash-paying patients under a federal framework announced last year. Summary: The approval increases competition in the growing oral GLP-1 market by adding another pill option alongside Novo Nordisk's Wegovy. Lilly has said it will seek further indications, including an application for diabetes, and public and private insurer coverage and wider availability remain to be determined.