Novo eyes fourth-quarter FDA verdict for oral Wegovy filing
Title
Novo Nordisk Awaits Fourth-Quarter FDA Decision on Oral Wegovy for Obesity
Keywords
- Novo Nordisk
- Oral Wegovy
- Semaglutide 25 mg
- FDA decision
- Obesity treatment
- GLP-1 analog
- Chronic weight management
- OASIS 4 trial
- Cardiovascular risk reduction
- First oral GLP-1 for obesity
Key Facts
- 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 condition14.
- The FDA decision on approval of oral Wegovy is expected in the fourth quarter of 20252345.
- If approved, this would be the first oral GLP-1 receptor agonist treatment specifically indicated for obesity, offering an alternative to injectable therapies34.
- 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-up34.
- 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 management24.
- 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 pill34.
Sources:
1. https://pharmaphorum.com/news/fda-decision-oral-wegovy-coming-q4
2. https://www.pharmabiz.com/NewsDetails.aspx?aid=177685&sid=2
3. https://medwatch.com/News/Pharma_Biotech/article18149361.ece
4. https://www.prnewswire.com/news-releases/fda-accepts-filing-application-for-oral-semaglutide-25-mg-which-if-approved-would-be-the-first-oral-glp-1-treatment-for-obesity-302445232.html
5. https://endpts.com/unity-lays-off-all-workers-novo-to-get-fda-decision-on-oral-wegovy-this-year/