FDA accepts filing application for oral semaglutide 25mg

Novo Nordisk has announced that the FDA accepted its New Drug Application (NDA) submission for an investigational once-daily, 25mg oral formulation of Wegovy (semaglutide) 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 (MACE) 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.

"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," said Dr Anna Windle, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "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."

The FDA application is based on results from OASIS 4, a 64-week phase 3 randomised, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25mg vs. placebo in 307 adults with obesity (BMI >/= 30 kg/m2) or overweight (BMI >/= 27 kg/m2) with one or more comorbidities. Patients with diabetes were excluded.

OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a seven-week off-treatment follow-up period. In total, 307 participants were randomised 2:1 ratio to once-daily oral semaglutide 25mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.

The FDA action date to decide on the Wegovy oral formulation NDA will be in the fourth quarter in 2025.