European regulators have approved Orexigen Therapeutics’ weight loss pill Mysimba (naltrexone/bupropion) for use alongside a reduced-calorie diet and increased physical activity.
Specifically, the European Commission has cleared the drug’s use in adults who are obese or those who are overweight and have one or more weight-related co-morbidities, such as type II diabetes or hypertension.
The decision comes on the back of a recommendation for approval by regulatory advisors back in December, based on clinical trials showing that more patients treated with Mysimba achieved clinically-relevant weight loss than patients treated with placebo.
Uncertainties with the drug’s long-term affect on the heart were highlighted at the time, and while interim clinical data were said to be “reassuring”, regulators have stipulated that patients should be monitored after 16 weeks’ treatment and only allowed to continue treatment if they have achieved at least 5% weight loss.
The drug was approved as Contrave in the US last September.