Orexigen: Mysimba Receives Positive CHMP Opinion Recommending Approval In EU

(RTTNews) - Orexigen Therapeutics (OREX) said the Committee for Medicinal Products For Human Use or CHMP of the European Medicines Agency 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 with an initial Body Mass Index of = 30 kg/m2, or = 27 kg/m2 to ? 30 kg/m2 in the presence of one or more weight-related co-morbidities like type 2 diabetes, dyslipidaemia, or controlled hypertension.

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.

Further, the CHMP 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.