Breaking: CHMP Recommends Approval of High-Dose Wegovy® (7.2 mg) for Obesity

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of a new, higher dose of Wegovy® (semaglutide 7.2 mg).

This major regulatory milestone brings a more potent option to patients in the European Union, offering the potential for significantly greater weight loss compared to the standard 2.4 mg maintenance dose.

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Key Takeaways

• New Dose Strength: 7.2 mg once weekly (previously capped at 2.4 mg).
• Efficacy: Clinical trials demonstrated an average weight loss of 20.7%.
• Target Audience: Adults with obesity (BMI ≥30) or overweight (BMI ≥27) with comorbidities.
• Next Step: Final approval from the European Commission is expected in early 2026.

Superior Weight Loss Results

The CHMP’s positive opinion is supported by data from the STEP UP Phase 3b trial. The study compared the efficacy of the new 7.2 mg dose against the standard 2.4 mg dose.

Key findings included:

• Greater Weight Reduction: Patients on 7.2 mg achieved a mean weight loss of 20.7% over 72 weeks, compared to 17.5% for those on the 2.4 mg dose.
• High Response Rate: Approximately one in three patients on the high dose achieved a weight loss of 25% or more.
• Muscle Preservation: Data indicated that the majority of weight lost was fat mass, with muscle function remaining intact.

Closing the Gap in Obesity Care

While the standard Wegovy® dose (2.4 mg) has been a game-changer, some patients hit a "plateau" or require more intensive intervention to reach healthy weight targets. The 7.2 mg dose aims to bridge the gap between pharmacotherapy and bariatric surgery results.

Martin Holst Lange, Executive Vice President at Novo Nordisk, stated that this new option will allow more people to achieve "clinically meaningful weight loss" that can improve long-term health outcomes.

Safety & Side Effects

The safety profile of the 7.2 mg dose was found to be consistent with the GLP-1 receptor agonist class. As with lower doses, the most common adverse events were gastrointestinal (nausea, vomiting, diarrhea). These were generally mild-to-moderate and diminished over time as patients adjusted to the medication.

What Happens Next?

A positive opinion from the CHMP is the final step before official marketing authorization. The European Commission typically follows this recommendation within 67 days. Once approved, the rollout across individual EU member states will depend on local pricing and reimbursement negotiations.

Follow E-PharmaTimes for updates on the official launch date and pricing of the 7.2 mg pen.

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Disclaimer: This article is for informational purposes only and does not constitute medical or pharma advice. Wegovy® is a prescription medication. Always consult your healthcare provider regarding treatment options suitable for your medical history.