Novo Nordisk A S — Saxenda EMA EPAR variation assessment report (EMEA/H/C/003780, 2015)
Novo Nordisk A S · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Novo Nordisk's Type II variation application for Saxenda (liraglutide) to extend its indication for weight management to obese children aged 6 to less than 12 years. Based on the 56-week, double-blind, placebo-controlled Study NN8022-4392, liraglutide 3.0 mg demonstrated statistically significant superiority over placebo in reducing BMI and body weight, with comparable efficacy across age groups despite higher exposure in children. While effective, the safety profile showed a higher incidence of gastrointestinal adverse events (vomiting, nausea, diarrhea) in the liraglutide group, mostly mild to moderate and occurring during dose escalation. The report highlights the need for continued monitoring of long-term pancreatic safety and includes a stopping rule for treatment discontinuation.
Key findings — cited to the page
| Number of sites | 25 | Study 4392 · Belgium, India, Israel, Malaysia, Mexico, Portugal, Russia, Switzerland, United States · p.30 |
| Duration of MTC registry | 15 years | NN2211-3965 MTC registry (MTC-22341) · United States · p.72 |
| Saxenda approval date for adolescents | 26 March 2021 | Saxenda · EU · p.9 |
| Type II variation application submission date | 24 July 2024 | Saxenda · p.6 |
| Saxenda approval date for adults | 23 March 2015 | Saxenda · EU · p.9 |
| Study 4181 N | 20 | Study 4181 · p.11 |
| Study 4181 duration | 7-13 week | Study 4181 · p.11 |
| Study 4392 N | 82 | Study 4392 · p.11 |
| Study 4392 duration | 56-week | Study 4392 · p.11 |
| Study 4181 randomization ratio | 2:1 | Study 4181 · p.11 |
| Study design | 56-week, double-blind, randomised, placebo-controlled study | NN8022-4392 · p.6 |
| Number of participants in E-R dataset | 4691 | Study 4392, Study 4180, Study 1807, Study 1839, Study 1922 · p.21 |
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 →