On May 2, 2025, the U.S. Food and Drug Administration accepted Novo Nordisk's marketing application for the experimental once-daily oral version of its blockbuster weight-loss drug Wegovy. This marks a critical step towards bringing an oral obesity treatment to market.
The acceptance of the application signals that the FDA has deemed the submission complete and ready for review. A decision is expected around the turn of the year, potentially making it the first oral GLP-1 treatment for obesity.
Oral semaglutide offers a significant convenience advantage over injectable therapies, which could expand the addressable market for obesity treatments. This development positions Novo Nordisk to capture a new segment of patients and further solidify its leadership in metabolic health.
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