Orexigen's Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) Receives Positive CHMP Opinion Recommending Approval for Weight Management in the European Union

LA JOLLA, California, Dec. 19, 2014 /PRNewswire/ -- Orexigen Therapeutics (NASDAQ: OREX) announced today that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a centralized marketing authorization for Mysimba™ (naltrexone HCI / bupropion HCI prolonged release), as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m² (obese), or ≥ 27 kg/m² to ˂ 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).

"The prevalence of obesity has more than tripled in many European countries in recent decades, and this rise in obesity has been accompanied with an increase in comorbid conditions including diabetes, cardiovascular complications, and fatty liver disease," said Nicholas Finer, BSc (Hons), MBBS, FRCP, Honorary Professor, National Centre for Cardiovascular Prevention and Outcomes, University College London Institute of Cardiovascular Science. "New treatment options are sorely needed in Europe where there is currently only one prescription drug available for weight management, a lipase inhibitor, which was approved in 1998. I am pleased the CHMP adopted a positive opinion for Mysimba after a careful assessment of its benefits and risks."

The CHMP opinion was based on the results of four Phase 3 clinical trials evaluating Mysimba in more than 4,500 overweight and obese patients including a dedicated clinical trial in obese patients with diabetes. The CHMP also reviewed the interim analysis of the Light Study, a cardiovascular outcomes safety trial with more than 8,900 patients evaluating the effects of Mysimba on heart attack, stroke and cardiovascular death.

The CHMP is responsible for scientific assessment of medicinal products seeking centralized marketing authorization throughout the European Union (EU) and EEA (European Economic Area). The CHMP's positive opinion is now referred to the European Commission for a binding decision to be adopted to grant a centralized marketing authorization for Mysimba. A positive decision will allow Mysimba to be placed on the market in all EU member states, and Iceland, Liechtenstein and Norway.