Mysimba™ By Orexigen Receives Positive CHMP Opinion and Recommendation For Weight Management In EU

Mysimba™ By Orexigen Receives Positive CHMP Opinion and Recommendation For Weight Management In EU

shutterstock_193863902Orexigen Therapeutics announced that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) recommends Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) for centralized marketing authorization as an adjunct to a reduced-calorie diet and increased physical activity, and a pharmacologic means to help manage weight in adults suffering from some obesity-related conditions such as hypertension, dyslipidaemia and type 2 diabetes.

Nicholas Finer from the University College London Institute of Cardiovascular Science said in a press release: “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. 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 recommendation is based on four Phase III clinical trials’ outcomes, involving more than 4,500 obese and over-weight patients. The CHMP also reviewed the Light Study that assessed 8,900 patients, with an aim to understand how Mysimba could be related with stroke, heart attack and cardiovascular death.

The CHMP’s recommendation has been forwarded to the European Commission. A positive answer will allow Mysimba to be commercially available across EU member states, along with IcelandLiechtenstein and Norway markets.

The CEO of Orexigen, Michael Narachi, said: “We are delighted with the CHMP opinion and look forward to the completion of the European Commission’s review in early 2015. With both the US approval and this positive endorsement by the CHMP, we will advance our plans for partnership and commercialization of Contrave and Mysimba across the globe.”

Estimates say that 20 percent of European’s adults are obese, a preventable condition that shortens life and can diminish the quality of life. It affects more people from lower socioeconomic groups and it is a major problem that society and science have to face together.

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