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Switzerland : ARENA PHARMACEUTICALS submits MAA in Switzerland.

As per the reports, Arena Pharmaceuticals, Inc. has filed with the Swiss health authority, Swissmedic, of a Marketing Authorization Application (MAA) for lorcaserin hydrochloride, an investigational drug candidate in Switzerland.

The intended indication is as an adjunct to diet and exercise for weight control in patients with an initial body mass index (BMI) of 30 kg/m(2) or greater (obese), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight related comorbid condition. Arena expects that Swissmedic will accept the filing later this month and confirm the filing is sufficiently complete to permit a substantive review process.

As part of the Swiss MAA, Arena submitted data from its three double-blind, randomized, placebo-controlled clinical trials, 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.

Jack Lief, Arena's President and Chief Executive Officer said, This submission reflects our continued efforts to make lorcaserin available to physicians and patients beyond the United States. 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.

2012 Al Bawaba (Albawaba.com)

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Publication:Mena Report
Date:Jul 16, 2012
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