1. EMA recommends new Wegovy® 7.2 mg for obesity treatment in the EU. 2. Wegovy® 7.2 mg shows 20.7% average weight loss after 72 weeks. 3. One-third of participants achieved over 25% weight loss; muscle function maintained. 4. Semiaglutide 7.2 mg is under review in the US, UK, and other countries. 5. Final approval from the European Commission is pending in early 2026.
FAQ
Why Bullish?
The positive EMA opinion could boost sales and market demand for Wegovy®, as demand for obesity treatments rises. Historical examples include successful launches of similar obesity drugs leading to significant revenue increases.
How important is it?
The EMA's positive recommendation enhances NVO's product portfolio and market position in the growing obesity treatment sector, significantly impacting its valuation.
Why Long Term?
Once approved, Wegovy® 7.2 mg will likely reshape the obesity treatment market, benefitting NVO's long-term performance. Historical data suggests sustained demand for effective obesity treatments contributes to long-lasting revenue growth.
Novo Nordisk A/S: EMA Recommends New 7.2 mg Dose of Wegovy® for Greater Weight Loss
The European Medicines Agency (EMA) has issued a positive opinion regarding a higher dose of Wegovy® (semaglutide 7.2 mg), marking a significant advancement for individuals struggling with obesity in the European Union (EU). This new dosage is projected to support an average weight loss of 20.7% over 72 weeks, offering a fresh option to enhance weight management efforts.
Weight Loss Efficacy of Wegovy® 7.2 mg
Results from the STEP UP clinical trial program demonstrate that individuals with obesity taking Wegovy® 7.2 mg experienced a remarkable 20.7% body weight loss at the 72-week mark. Notably, one in three participants achieved a weight reduction of 25% or more during the same period.
These findings contrast favorably with the health benefits of the previously established Wegovy® 2.4 mg dosage. Participants reported not only substantial weight loss but also improvements in obesity-related complications, including a significant reduction in the risk of cardiovascular events such as heart attacks and strokes.
Insights from Clinical Trials
The EMA's positive opinion is primarily based on the findings from the STEP UP and STEP UP T2D trials. In these studies, individuals with obesity—both those with and without type 2 diabetes—received treatments that confirmed that approximately 84% of the weight lost derived from fat mass, while preserving muscle function.
- In the STEP UP trial involving 1,407 adults, participants showcased greater weight loss with semaglutide 7.2 mg compared to placebo.
- One in three adults treated achieved substantial weight loss, underscoring the efficacy of the semaglutide formulation.
Future Availability and Regulatory Insights
Ludovic Helfgott, executive vice president at Novo Nordisk, commented on the potential of the new dose, stating, “This positive opinion means a new Wegovy® option, delivering weight loss of 20.7%, could be available for people with obesity early in the new year.”
In tandem with the EMA application for Wegovy® 7.2 mg, Novo Nordisk has also requested approval for a single-dose delivery device. The company is concurrently seeking regulatory approvals for the new formulation in the US, UK, and other international markets.
About Novo Nordisk and Wegovy®
Founded in 1923, Novo Nordisk is a leading healthcare company based in Denmark, dedicated to pioneering solutions for chronic diseases such as diabetes. Wegovy® is prescribed as an adjunct treatment to a reduced-calorie diet and increased physical activity, specifically for adults with obesity and those with overweight conditions accompanied by weight-related comorbidities.
Currently, Wegovy® is also indicated for use in pediatric patients aged 12 years and older with an obesity diagnosis, illustrating the treatment's comprehensive applicability.