Novo Nordisk A S — Saxenda EMA EPAR public assessment report (EMEA/H/C/003780, 2015)
Novo Nordisk A S · 2015 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Saxenda (liraglutide 3.0 mg) for chronic weight management in adults with obesity or overweight with comorbidities. Identical to Victoza's active substance but at a higher dose, Saxenda demonstrated significant weight loss (7.5% vs. 2.3% placebo, 5.2% placebo-subtracted) and improved glycemic control in clinical trials. Non-clinical studies confirmed quality and low human relevance of rodent tumor findings. Pharmacokinetic and pharmacodynamic analyses supported its mechanism. Safety concerns included increased gastrointestinal events, pulse rate, gallstone disease, and pancreatitis, though the overall benefit-risk balance was deemed positive. A stopping rule recommends discontinuation if 5% weight loss isn't achieved after 12 weeks.
Key findings — cited to the page
| Response of at least 10% weight loss | 50.1 % | Saxenda · p.63 |
| BMI for obesity definition | 30 kg/m2 | United States, Europe · p.10 |
| Total number of subjects in clinical development program for liraglutide weight management | 5813 | Global · p.33 |
| Expected mean weight change after one year (not corrected for placebo) | -10.82 % | Saxenda · p.63 |
| Stopping rule for Saxenda treatment | discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight | Saxenda · p.63 |
| Mean weight loss | 7.5 % | Saxenda · p.63 |
| Mean weight loss | 7.8 kg | Saxenda · p.63 |
| Mean weight loss (placebo) | 2.3 % | Saxenda · p.63 |
| Mean weight loss (placebo) | 2.5 kg | Saxenda · p.63 |
| Placebo-subtracted weight loss | 5.2 % | Saxenda · p.63 |
| Estimated treatment effect (conservative methods) | -4.28 % | Saxenda · p.63 |
| Patients exposed to liraglutide for proposed indication | 3872 patients | Saxenda · p.63 |
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 →