Novo Nordisk A S — Wegovy EMA EPAR public assessment report (EMEA/H/C/005422, 2022)
Novo Nordisk A S · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the European Medicines Agency's assessment of Wegovy (semaglutide) for weight management. It details the comprehensive clinical development program, including four Phase 3a trials (STEP trials), demonstrating semaglutide's efficacy in significant body weight reduction, improved glycemic control, and positive cardiovascular outcomes in overweight/obese individuals. Preclinical studies confirmed its mechanism of action and safety profile, though some animal findings were noted. Pharmacokinetic and pharmacodynamic analyses highlighted its effects on energy intake, glucose metabolism, and fat tissue reduction. While gastrointestinal adverse events were common and dose-dependent, the overall safety profile was consistent with other GLP-1 RAs. The benefit-risk balance for Wegovy is considered positive for weight management. Ongoing trials address long-term effects and specific populations.
Key findings — cited to the page
| Semaglutide potency (cAMP production) | 0.15 nM | · p.25 |
| ATC Code | A10BJ06 | · p.2 |
| Marketing authorisation application submission date | 17 December 2020 | Wegovy · p.9 |
| Procedure No. | EMEA/H/C/005422/0000 | Wegovy · p.1 |
| Trial subjects | 336 | Trial 4576 (STEP 8) · United States · p.15 |
| Applicant | Novo Nordisk A/S | · p.2 |
| Number of subjects | 336 | Trial 4576 (STEP 8) · United States · p.38 |
| Number of completed clinical trials | 8 | Wegovy · Global · p.13 |
| Number of Phase 3a therapeutic confirmatory trials | 4 | Wegovy · Global · p.13 |
| Cut-off date for completed trials | 28 October 2020 | Wegovy · Global · p.13 |
| International non-proprietary name | semaglutide | Wegovy · p.1 |
| Active substance | Semaglutide | Wegovy · p.2 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →