Novo eyes fourth-quarter FDA verdict for oral Wegovy filing

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Novo Nordisk Awaits Fourth-Quarter FDA Decision on Oral Wegovy for Obesity

The FDA has accepted Novo Nordisk’s New Drug Application (NDA) for a 25 mg, once-daily oral formulation of Wegovy (semaglutide) targeted for chronic weight management in people with obesity or overweight and at least one comorbid condition1 4.
The FDA decision on approval of oral Wegovy is expected in the fourth quarter of 20252 3 4 5.
If approved, this would be the first oral GLP-1 receptor agonist treatment specifically indicated for obesity, offering an alternative to injectable therapies3 4.
The NDA is supported by results from the OASIS 4 Phase 3 trial, which assessed the efficacy and safety of oral semaglutide 25 mg in 307 adults with obesity or overweight, including a dose escalation phase and treatment-free follow-up3 4.
The filing also seeks an indication for reducing major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease4.
Wegovy’s approved injectable formulation (semaglutide 2.4 mg) is already available for obesity management2 4.
Novo Nordisk’s announcement led to a rise in its stock price, reflecting investor optimism about the potential approval and market expansion3.
The move marks a significant advance in obesity care, providing patients with more individualized and convenient treatment options, including a daily pill3 4.