EMA has recommended an extension to the EU marketing authorisation for Wegovy to add an oral formulation for weight management.
Key points
-
Wegovy tablets would be used with diet and physical activity in adults with obesity, or in overweight adults with at least one weight-related comorbidity.
-
The tablets are taken once daily on an empty stomach, after at least 8 hours of fasting, and users should wait 30 minutes before eating, drinking, or taking other medicines.
-
This is the first GLP-1 receptor agonist for weight management developed for oral use.
-
In a phase 3 trial of 307 adults, participants taking Wegovy tablets lost 13.61% of body weight on average, versus 2.18% with placebo.
-
The most common side effects were gastrointestinal disorders, and the safety profile was similar to weekly Wegovy injections.
The CHMP opinion now goes to the European Commission for a decision. If the extension is granted, price and reimbursement decisions will follow in each Member State.
Read more at https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-weight-management
