CHMP recommends Mysimba for treatment of Obesity- Orexigen Therapeutics
Orexigen Therapeutics has announced 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 (more than 18 years) with an initial Body Mass Index (BMI) of more than 30 kg/m2 (obese), or more than 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 recommendation came with a qualification, that if patients have not lost at least 5% of their body weight after 16 weeks, that the drug be stopped. That is because of unknown but potential cardiovascular risks after prolonged use.
Ths North American rights to the drug, known as Contrave in the US are licensed to Takeda.
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