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Switzerland : MAA filed by Arena Pharmaceuticals for obesity drug in Switzerland.

Marketing authorization application, or MAA is being filed by Arena Pharmaceuticals, Inc., a biopharmaceutical company with the Swiss health authority, Swissmedic, for lorcaserin hydrochloride, an investigational drug candidate in Switzerland.

With an initial body mass index (BMI) of 30 kg/m or greater (obese), or 27 kg/m or greater (overweight) in the presence of at least one weight related comorbid condition, intended indication is as an adjunct to diet and exercise for weight control in patients.

The filing will later accepted by Swissmedic this month and confirm the filing is sufficiently complete to permit a substantive review process, expected by Arena.

Data from its three double-blind, randomized, placebo-controlled clinical trials is submitted by Arena, which demonstrated that lorcaserin along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. In these trials, the most common adverse reactions for patients without diabetes treated with lorcaserin were headache, dizziness, fatigue, nausea, dry mouth, and constipation, as part of the Swiss MAA.

The third marketing application submitted to date for lorcaserin is the MAA filing in Switzerland. The FDA under the trade name BELVIQ in June 2012 is apporved by Lorcaserin and is currently under review with the European Medicines Agency (EMA). Switzerland is not part of the EMA and requires an independent application and approval from Swissmedic.

Food consumption is decreased by satiety is promoted by selectively activating serotonin 2C receptors in the brain, believed by Lorcaserin. A person may be helped by Activation of these receptors to eat less and feel full after eating smaller amounts of food.

"This submission reflects our continued efforts to make lorcaserin available to physicians and patients beyond the US," said Jack Lief, Arena's President and CEO. "We look forward to Swissmedic's review of our application and to the potential approval of lorcaserin in Switzerland for patients who are obese or overweight with comorbidities."

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Publication:Mena Report
Date:Sep 7, 2012
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