Eli Lilly has secured U.K. approval for Foundayo, clearing the company’s first sale of the weight-loss pill outside the U.S. and setting up a direct challenge to Novo Nordisk’s Wegovy pill in Europe. The decision makes Foundayo only the second GLP-1 weight-loss pill available in the European market, arriving two months after Novo introduced oral Wegovy in the region. The U.K.’s Medicines and Healthcare products Regulatory Agency approved orforglipron, marketed as Foundayo, for prescription use in weight management and type 2 diabetes. Initial availability will be through private prescriptions, while broader access through the National Health Service depends on a cost-effectiveness assessment by NICE. Lilly said it plans to launch the drug in the U.K. later this month at a list price below its injectable diabetes medicine Mounjaro, which costs £330 for a month’s supply. Lilly shares rose about 2% in early U.S. trading after the announcement. Lilly is pitching Foundayo’s convenience as a competitive edge because, as a small molecule medicine, it can be taken without food or water restrictions, unlike Wegovy, which must be taken first thing in the morning with a small amount of water and no food, beverages, or other medicines for at least 30 minutes. Foundayo’s U.S. launch on April 1 has so far trailed the Wegovy pill, with second-quarter sales of $98 million. Lilly CEO David Ricks said the slower uptake reflected the challenge of introducing a completely new medicine, in contrast with Wegovy, which uses semaglutide, the same active ingredient as Novo’s injectable versions. Novo CEO Mike Doustdar has said the weight-loss market could become largely oral over time and that about 300,000 patients were expected to have started oral Wegovy within the first three weeks of its U.K. launch. Foundayo is also under review in the European Union, while oral Wegovy has received a positive recommendation from the European Medicines Agency and is awaiting a final European Commission decision.