By Fineline Cube 
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy (semaglutide 7.2 mg). The new dose demonstrated an average weight loss of 20.7% at 72 weeks in people with obesity without diabetes.
Regulatory & Development Updates
| Region | Status | Details |
|---|---|---|
| European Union | CHMP positive opinion for 7.2 mg | Single-dose device application submitted |
| United States | Under review; CNPV received | FDA submission: November 2025; 1‑2 month review expected |
| UK & Others | Under review | Multiple regulatory submissions underway |
Clinical Results & Label Expansion
| Dose | Weight Loss | Population |
|---|---|---|
| Wegovy 7.2 mg | 20.7% average at 72 weeks | Obesity without diabetes |
| Wegovy 2.4 mg (EU label) | Proven weight management | Adults: BMI ≥30 kg/m² or ≥27 kg/m² with comorbidity; Pediatrics: ≥12 years, BMI ≥95th percentile, >60 kg |
Expanded Label Benefits (EU 2.4 mg):
- MACE risk reduction (major adverse cardiovascular events)
- HFpEF symptom improvement (heart failure with preserved ejection fraction)
- Knee osteoarthritis pain reduction
Market Opportunity
| Metric | Value | Implication |
|---|---|---|
| Global Obesity Market | $35 billion (2025) | Projected $60 billion by 2030 |
| Wegovy Peak Sales | $15‑20 billion (global estimate) | 7.2 mg dose expands eligible patient population |
| Competitive Position | First GLP‑1 with 20%+ weight loss | Differentiates from Lilly’s tirzepatide (~15‑20%) |
| Pediatric Market | First GLP‑1 approved for adolescents ≥12 in EU | Expands addressable population |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Wegovy’s regulatory approvals, market projections, and label expansions. Actual results may differ due to regulatory delays, competitive responses, or safety profile changes.-Fineline Info & Tech