Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H/C/003687, 2015)

Orexigen · 2015 · EMA EPAR public assessment report

Report summary

This EMA public assessment report details the marketing authorization application for Mysimba (naltrexone/bupropion) for obesity management. It covers the product's quality, manufacturing, non-clinical toxicology, pharmacokinetics, and environmental risk. Clinical trials demonstrated significant weight loss, with doses like N32/B400 showing superior efficacy compared to placebo, particularly in subjects with type 2 diabetes. Common adverse events included nausea, headache, and insomnia. Cardiovascular safety concerns, including MACE and blood pressure increases, were noted, leading to a post-marketing cardiovascular outcomes trial. The report concludes that Mysimba's benefits outweigh its risks for the approved indication, with ongoing safety monitoring and risk minimization strategies.

Key findings — cited to the page

number of production scale batches for process validation	3	Mysimba · p.17
LS mean percent change in total body weight	-3.6 %	Study OT-101 · p.45
Indication BMI threshold with risk factors	≥27 kg/m2	Mysimba · p.7
CHMP positive opinion date	18 December 2014	Mysimba · EU · p.9
Marketing Authorisation Application submission date	2 October 2013	Mysimba · EU · p.7
Eligibility to centralised procedure agreement date	17 January 2013	Mysimba · EU · p.7
Phase	2	Study OT-101 · p.45
US Marketing Authorisation date	10 September 2014	Mysimba · United States · p.8
Naltrexone dose	8 mg	Mysimba · p.12
Bupropion dose	90 mg	Mysimba · p.12
LS mean percent change in total body weight	-4.0 %	Study OT-101 · p.45
LS mean percent change in total body weight	-2.0 %	Study OT-101 · p.45

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 →