The U.S. Food and Drug Administration (FDA) has accepted Novo Nordisk’s New Drug Application (NDA) for a 25 mg oral formulation of Wegovy (semaglutide), marking a significant step toward potentially introducing the first oral GLP-1 receptor agonist for chronic weight management.
Here are five key points to understand about this development:
1. First Oral GLP-1 Therapy for Obesity
If approved, this would be the first oral GLP-1 receptor agonist therapy indicated for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity.
2. Based on OASIS 4 Clinical Trial
The NDA submission is supported by results from the OASIS 4 phase 3 trial, which evaluated the efficacy and safety of once-daily oral semaglutide 25 mg in 307 adults with obesity or overweight and at least one comorbidity. The trial demonstrated significant weight loss and improvements in cardiometabolic risk factors compared to placebo.
3. Potential for Increased Accessibility and Adherence
An oral formulation could offer a more convenient alternative to injectable GLP-1 therapies, potentially improving patient adherence and expanding access to weight management treatments.
4. FDA Decision Expected in Late 2025
The FDA has set an action date for the fourth quarter of 2025 to decide on the approval of the oral Wegovy formulation.
5. Competitive Landscape in Obesity Treatments
Novo Nordisk’s move comes amid increasing competition in the obesity treatment market, with companies like Eli Lilly developing their own oral GLP-1 therapies. The approval of oral Wegovy could strengthen Novo Nordisk’s position in this rapidly evolving field.
The FDA’s acceptance of the application marks a key milestone for Novo Nordisk as it seeks to expand its presence in the obesity treatment market. With a final decision expected in late 2025, the outcome could reshape how GLP-1 therapies are administered and signal a broader shift toward more accessible treatment options for millions of Americans living with obesity.
