Novo Nordisk reports FDA accepts filing application for oral semaglutide 25 mg

Novo Nordisk (NVO) announced that the U.S. Food and Drug Administration accepted its New Drug Application submission for an investigational once-daily, 25 mg oral formulation of Wegovy for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease. “If approved, Wegovy would become the first oral formulation of a GLP-1 indicated for chronic weight management,” the company stated. The FDA action date to decide on the Wegovy oral formulation NDA will be in Q4 2025, the company added. “We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations. Novo Nordisk’s strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity,” said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk.