Novo Nordisk A S — Ozempic EMA EPAR public assessment report (EMEA/H/C/004174, 2018)
Novo Nordisk A S · 2018 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Ozempic (semaglutide) for type 2 diabetes. Semaglutide, a GLP-1 receptor agonist, is designed for once-weekly dosing due to its extended half-life. It effectively lowers HbA1c and body weight, with dose-dependent effects. Clinical trials demonstrated superiority over comparators in glycemic control and weight reduction, and non-inferiority for major adverse cardiovascular events (MACE), with a trend towards superiority. Key safety concerns include increased gastrointestinal adverse events, a non-dose-related increase in heart rate, and an elevated risk of diabetic retinopathy complications, particularly in patients with pre-existing retinopathy and insulin co-use. Gallbladder-related adverse events were also more frequent. Despite these, the overall benefit-risk balance for Ozempic is considered positive for adults with inadequately controlled type 2 diabetes. Manufacturing and quality controls are robust, supporting product stability.
Key findings — cited to the page
| Number of ongoing trials for semaglutide | 1 | · p.11 |
| Shelf-life of semaglutide active substance | 60 months | · p.15 |
| Number of completed Phase 2 studies for semaglutide | 1 | · p.11 |
| Number of completed Phase 3 studies for semaglutide | 8 | · p.11 |
| Application submission date | 5 December 2016 | Ozempic · p.7 |
| Number of in vitro studies for semaglutide | 9 | · p.11 |
| GLP-1 half-life after i.v. administration | <1.5 minutes | · p.10 |
| Number of completed Phase 1 studies for semaglutide | 16 | · p.11 |
| Mean t½ in subjects with T2D | 155 hours | · p.37 |
| EMA/CHMP eligibility agreement date | 26 February 2015 | · p.7 |
| CHMP positive opinion date | 14 December 2017 | · p.9 |
| Concentration of semaglutide finished product | 1.34 mg/ml | · p.15 |
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 →