European Commission Approves Enhanced Wegovy Obesity Treatment Dose
European Commission Backs Wegovy Obesity Treatment with 7.2 mg Dose
The European Commission has approved a higher 7.2 mg maintenance dose of Wegovy® (semaglutide injection) for adults with obesity requiring additional weight loss support beyond the standard 2.4 mg dose, marking a significant expansion of Wegovy obesity treatment options across all 27 European Union (EU) countries. This approval, based on clinical evidence from the STEP UP and STEP UP T2D trials, demonstrates that patients achieved an average 21% body weight loss with the 7.2 mg dose combined with lifestyle interventions, compared to 2% with placebo. Consequently, Wegovy® now offers six once-weekly injectable doses (0.25 mg to 7.2 mg), enhancing physician flexibility in tailoring therapy while preserving muscle function.
STEP UP Trials Deliver 21% Weight Loss Milestone
Central to the approval are findings from the STEP UP trial involving 1,407 adults with obesity (without type 2 diabetes) and the STEP UP T2D trial with 512 participants (with type 2 diabetes), both spanning approximately 1½ years. Participants on the 7.2 mg dose, administered as three 2.4 mg injections weekly after at least four weeks on 2.4 mg, achieved 21% average body weight reduction when adhering to treatment, with about one in three losing 25% or more; body composition analysis revealed 84% of weight loss derived from fat mass, alongside preserved muscle function. These outcomes substantially outperformed placebo (2% loss), with common mild-to-moderate, transient side effects including nausea, diarrhea, vomiting (24.8%), and dysaesthesia (22.9%). This evidence underscores the dose’s role in delivering clinically meaningful weight reduction for Wegovy obesity treatment, transitioning seamlessly to broader therapeutic applications.
CHMP Opinion Paves Way for Direct Dose Escalation
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 12 December 2025, enabling direct escalation from 2.4 mg to 7.2 mg for enhanced weight management in adults with initial body mass index (BMI) ≥30 kg/m² (obesity) or ≥27 kg/m² (overweight) with comorbidities, alongside reduced-calorie diet and physical activity. The randomized, placebo-controlled STEP trials evaluated efficacy and safety in diverse populations, incorporating body composition assessments to confirm fat-specific loss and muscle preservation. Novo Nordisk’s pending application for a single-dose 7.2 mg pen could further streamline administration, building on Wegovy®’s established indications, including pediatric use and benefits in major adverse cardiovascular events risk reduction, heart failure with preserved ejection fraction symptoms, and knee osteoarthritis pain.
EU Market Access and Cost Savings
This approval positions Wegovy obesity treatment as a more potent option in the EU obesity market, potentially demonstrating superior weight loss (21% average) that could reduce long-term costs associated with obesity-related comorbidities like type 2 diabetes and cardiovascular disease. The dose escalation offers payers evidence of value through preserved muscle function and high response rates (e.g., 33% achieving ≥25% loss), supporting arguments for broader formulary inclusion amid rising demand for glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
