By Fineline Cube 
Denmark-based Novo Nordisk (NYSE: NVO) announced that its New Drug Application (NDA) filing for its once-daily, 25 mg oral formulation of Wegovy (semaglutide) has been accepted for review by the US Food and Drug Administration (FDA). This marks a significant step toward the potential approval of the first oral formulation of a GLP-1 indicated for chronic weight management.
Indications and Potential Impact
Oral Wegovy is designed for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions. It is also intended to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease. If approved, the drug would become the first oral formulation of a GLP-1 receptor agonist for chronic weight management, offering a new treatment option for patients.
Clinical Trial Results
Novo Nordisk leveraged positive results from the Phase III OASIS 4 study for the NDA submission. The 64-week randomized, controlled Phase III trial evaluated the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with one or more comorbidities. The study demonstrated that oral administration of semaglutide effectively reduced the weight of subjects, along with good tolerability.-Fineline Info & Tech