Orexigen Gets EU Nod for Weight-Management Drug

Orexigen Therapeutics, Inc., a San Diego-based pharmaceutical company, reports that the European Commission has granted marketing authorization for Mysimba (naltrexone HCl / bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients who are overweight or obese as defined by specific body mass index measurements in the in the presence of one or more weight-related co-morbidities (e.g., Type 2 diabetes, dyslipidaemia, or controlled hypertension). This authorization applies to all 28 European Union (EU) member states.

Mysimba is a centrally acting anti-obesity product composed of a fixed dose combination of the active substances naltrexone and bupropion. Naltrexone is a mu-opioid antagonist, and bupropion is a norepinephrine and dopamine reuptake inhibitor. Both compounds affect key circuitry in two areas of the brain. The first is the arcuate nucleus of the hypothalamus, an area of the brain that plays a critical role in the control of food intake and energy expenditure. The second is the mesolimbic dopaminergic reward system, a region of the brain that is important for processing the rewarding aspects of food and food related stimuli. Both bupropion and naltrexone act in the mesolimbic reward system to influence eating behavior.

The drug was approved in the US in September 2014 and is marketed under a separate brand name.

Also in 2014, the US Food and Drug Administration approved Novo Nordisk’s weight management drug, Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a BMI of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia). The drug was approved in the European Union for this indication. Saxenda is the brand name of liraglutide 3 mg, a once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity; liraglutide is also the active ingredient in Novo Nordisk’s Type II diabetes treatment, Victoza.

Source: Orexigen Therapeutics

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