- EMA issued a positive opinion for Wegovy® 7.2 mg dose.
- Wegovy® 7.2 mg showed 20.7% weight loss at 72 weeks in trials.
- 84% of weight loss from Wegovy® was fat mass, preserving muscle.
- Semaglutide 7.2 mg is under review in the US, UK, and other countries.
EMA's Positive Opinion
The European Medicines Agency (EMA) has given a positive opinion for a new 7.2 mg dose of Wegovy® (semaglutide), moving it closer to availability in the EU. This higher dose aims to provide individuals with obesity an option for greater weight loss.
Clinical Trial Results
In the STEP UP programme, participants with obesity who took Wegovy® 7.2 mg experienced an average weight loss of 20.7% over 72 weeks. Notably, one in three participants achieved a weight loss of 25% or more. The trials also confirmed that 84% of the weight loss was from fat mass, with muscle function preserved.
Health Benefits
Wegovy® not only aids in weight loss but also offers established health benefits, such as reducing the risk of cardiovascular events like heart attacks and strokes, and alleviating pain from knee osteoarthritis.
Regulatory Status
Pending the European Commission's final approval, the new dose could be available early next year. Additionally, Novo Nordisk has applied for a single-dose device to deliver Wegovy® 7.2 mg. The semaglutide 7.2 mg is also under review in the US, UK, and several other countries, with an expedited review expected in the US following the FDA's acceptance of the filing.
