Novo Nordisk's Oral Wegovy Advances Towards FDA Approval, Marking Potential Milestone in Obesity Treatment

In a significant development for the pharmaceutical industry and obesity treatment, Novo Nordisk has taken a crucial step forward in its quest to introduce the first FDA-approved GLP-1 weight-loss pill. The company's New Drug Application (NDA) for an oral formulation of its popular obesity drug Wegovy has been accepted by the FDA, setting the stage for a potential market-changing approval later this year.

FDA Acceptance and Anticipated Timeline

The FDA's acceptance of Novo Nordisk's NDA for oral Wegovy marks a critical milestone in the drug's journey to market. While a specific action date has not been disclosed, the company has announced that the FDA's decision is expected in the fourth quarter of this year. If approved, the oral formulation would be administered as a 25-mg dose, taken once daily by adults who are overweight or obese and have at least one weight-related comorbid condition.

Clinical Data Supporting the Application

The NDA is supported by compelling results from the Phase III OASIS 4 study, which demonstrated the efficacy of oral Wegovy in comparison to both the injectable form and a placebo. Key findings from the study include:

• Oral Wegovy matched the weekly injectable form in terms of bodyweight reduction.
• Participants taking oral Wegovy experienced an average weight loss of 13.6%, compared to 2.4% in the placebo group.
• The safety profile of the oral formulation was consistent with that of the injectable version, with common side effects including nausea, diarrhea, constipation, and abdominal pain.

Competition in the Weight-Loss Market

Novo Nordisk's progress with oral Wegovy comes amid intense competition in the rapidly evolving weight-loss drug market. Notably, Eli Lilly is also in the race to develop an oral GLP-1 treatment for weight management:

• Lilly's orforglipron has shown promise in recent clinical trials, demonstrating significant reductions in blood glucose levels and body weight in patients with type 2 diabetes.
• Lilly CEO David Ricks has indicated that the company plans to file for approval of orforglipron for chronic weight management later this year, with a subsequent application for type 2 diabetes treatment expected in 2026.

As the pharmaceutical industry continues to focus on developing innovative treatments for obesity and related conditions, the potential approval of oral Wegovy could represent a significant advancement in patient care and market dynamics. The coming months will be crucial as both Novo Nordisk and Eli Lilly vie to bring the first oral GLP-1 weight-loss medication to market.