- The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the authorization of Novo Nordisk A/S's (NYSE:NVO) Wegovy for chronic weight management in adults with obesity.
- Wegovy is a once-weekly semaglutide 2.4 mg injection.
- The positive CHMP opinion is based on the STEP phase 3a trial program results that showed an average weight loss of 17-18% sustained over 68 weeks.
- Wegovy demonstrated a safe and well-tolerated profile across the program, with the most common adverse events being gastrointestinal.
- Novo Nordisk expects to receive final marketing authorization from the European Commission in approximately two months.
- In September 2021, Wegovy was approved by the U.K. Medicines and Health products Regulations Agency (MHRA).
- Novo Nordisk expects to launch Wegovy in Europe in 2H of 2022.
- Related Link: Novo Nordisk's Semaglutide Gets FDA Approval to Tackle Obesity.
- Price Action: NVO shares are up 0.59% at $113.37 during the market session on the last check Thursday.
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