Lilly’s weight-loss pill wins FDA approval

For the first time, regulators have approved a small-molecule pill targeting glucagon-like peptide 1 (GLP-1) for weight loss. The once-daily oral medicine, developed by Eli Lilly and Company, will be an option for people who may not want to take the popular range of GLP-1 injections. The pill contains the active ingredient orforglipron and will be sold under the brand name Foundayo. It will be shipped to patients with prescriptions starting April 6, the company says in a press statement. Foundayo’s most direct competitor will be an oral version of Novo Nordisk’s Wegovy that the US Food and Drug Administration approved in December. Its active ingredient is the peptide semaglutide, the same ingredient used in Novo Nordisk’s injectable weight-loss drug. Foundayo can be taken at any time of day without food or water restrictions, Lilly says. In contrast, the Wegovy pill needs to be taken on an empty stomach immediately upon waking, with no more than about 118 mL of water, and the patient must wait half an hour before eating, drinking, or taking other medication.“We think on-time approval and no food effect restrictions make orforglipron slightly more favorable vs oral [Wegovy] pill, which does have a food effect, but again net-net both are similar and can help expand and split the market,” UBS Bank analysts wrote to clients on April 1.The FDA’s approval of Lilly’s molecule is based on the company’s Phase 3 clinical trials, which showed that participants lost an average of 12.0% of their body weight after