FDA approves Novo Nordisk's Wegovy pill for weight loss, based on OASIS trial demonstrating 16.6% mean weight loss. One-third experienced 20%+ weight loss. First GLP-1 receptor agonist for weight management.

The FDA has recently given approval for Novo Nordisk A/S' Wegovy pill, which contains once-daily oral semaglutide 25 mg, as a treatment to assist in reducing excess body weight and maintaining long-term weight reduction, as well as lowering the risk of major adverse cardiovascular events. This makes the Wegovy pill the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy to be approved for weight management. The approval was granted after reviewing data from the OASIS trial program and the SELECT trial. In the OASIS 4 trial, where oral semaglutide 25 mg was taken once daily, participants with obesity or overweight and one or more comorbidities experienced a mean weight loss of 16.6% when treatment was consistently followed. The weight loss results seen with the Wegovy pill were comparable to those achieved with the injectable Wegovy 2.4 mg. Additionally, one-third of participants in the OASIS 4 trial reported a weight loss of 20% or more. Novo Nordisk is now preparing to launch the Wegovy pill in the market.