Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the filing 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.
"This submission reflects our continued efforts to make lorcaserin available to physicians and patients beyond the United States," said Jack Lief, Arena's President and Chief Executive Officer. "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."
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. In these trials, the most common adverse reactions for patients without diabetes treated with lorcaserin were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
The MAA filing in Switzerland is the third marketing application submitted to date for lorcaserin. Lorcaserin was approved by the US Food and Drug Administration (FDA) under the trade name BELVIQ in June 2012, 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.
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