Orexigen — Mysimba EMA EPAR variation assessment report (EMEA/H/C/003687, 2015)
Orexigen · 2015 · EMA EPAR variation assessment report
Report summary
This report summarizes the EMA's assessment of Mysimba (naltrexone/bupropion) for obesity, focusing on persistent cardiovascular (CV) safety concerns. Despite initial interim CV outcome trial results (NB-CVOT-1) suggesting no increased risk and demonstrating weight loss, subsequent trials were inadequate or terminated, leaving long-term CV safety uncertain. The ongoing NB-CVOT-3 (INFORMUS) study aims to address this, with results expected by 2028. While Mysimba shows statistically significant weight reduction, the benefit-risk balance remains under scrutiny due to these safety gaps. Risk minimization includes updated product information and a prescriber guide, emphasizing discontinuation if 5% weight loss isn't maintained after one year.
Key findings — cited to the page
| IRR (95% CI) (all time) | 0.76 (0.59, 0.98) | LIGHT trial · p.10 |
| Study medication discontinuation rate (placebo arm) | 84.0 % | NB-CVOT-1 (LIGHT) study · p.7 |
| Expected results date for alternative phase 4 pragmatic trial | 2027 | · p.6 |
| Number of initiations for lorcaserin | 12171 | United States · p.11 |
| CVOT study results submission deadline | end of March 2022 | NB-CVOT · p.6 |
| Patients randomized | 2825 | NB-CVOT-3 (INFORMUS) · United States · p.15 |
| MACE events (naltrexone/bupropion arm) | 35 | NB-CVOT (LIGHT trial) · p.6 |
| Total subjects treated with naltrexone/bupropion (clinical study program) | 9573 | · p.7 |
| Total subjects treated with placebo (clinical study program) | 7184 | · p.7 |
| Post-marketing exposure (patient years) | 716257 patient years | · p.7 |
| Post-marketing exposure (patient years) | 114680 patient years | European Economic Area · p.7 |
| Number of initiations for Contrave/Mysimba | 12475 | United States · p.11 |
Source: Orexigen ↗ · 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 →