Novo Nordisk A S — Ozempic EMA EPAR variation assessment report (EMEA/H/C/004174, 2018)
Novo Nordisk A S · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
This report details the EMA's positive assessment of Novo Nordisk A/S's application for a new 2 mg Ozempic (semaglutide) strength for adults with insufficiently controlled type 2 diabetes. The new strength, intended as an adjunct to diet and exercise, received a positive CHMP opinion on November 11, 2021. The assessment included stability, manufacturing, non-clinical, and clinical data. The SUSTAIN FORTE trial (NN9535-4506) demonstrated the 2.0 mg dose's superiority over 1.0 mg in reducing HbA1c and body weight, though the benefits were modest. Pharmacokinetic data and a phase 2 dose-finding study also supported the higher dose. Safety profiles were comparable between the 1.0 mg and 2.0 mg doses, with gastrointestinal disorders being the most common adverse events, slightly more frequent in the 2.0 mg arm. No new safety concerns were identified, and the overall safety profile was consistent with the GLP-1 RA class. Ongoing pharmacovigilance studies address specific concerns. The CHMP concluded a positive benefit-risk balance for the 2.0 mg dose, recommending its approval.
Key findings — cited to the page
| Trial design | multinational, multi-centre, randomised, double-blind, two-armed, active-comparator trial | · p.35 |
| Randomised subjects | 961 | · p.29 |
| Number of phase 3 trials in SUSTAIN program | 11 | SUSTAIN · Global · p.10 |
| Trial identifier | NN9535-4506 | · p.35 |
| CHMP positive opinion date | 11 November 2021 | Ozempic · p.8 |
| Treatment duration | 40 weeks | · p.36 |
| Phase 3b trial supporting 2.0 mg semaglutide | NN9535-4506 | · p.8 |
| New strength of Ozempic | 2 mg | Ozempic · p.6 |
| Approved maintenance doses of semaglutide | 0.5 and 1.0 mg | Ozempic · Global · p.8 |
| Patients not achieving HbA1c <7.0% with semaglutide 1.0 mg | 20-30 % | SUSTAIN · p.10 |
| Number of subjects in SUSTAIN program | 11000 | SUSTAIN · Global · p.10 |
| Randomisation ratio | 1:1 | · p.38 |
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 →