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FDA wants more data for lorcaserin

October 26, 2010 12:38 AM UTC

FDA issued a complete response letter for an NDA from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) for lorcaserin to treat obesity. According to Arena, FDA said that the efficacy of lorcaserin in patients without Type II diabetes is "marginal" and recommended that Arena submit the final report from the BLOOM-DM trial, which enrolled patients with Type II diabetes. Arena expects to report top-line data in the next few weeks and have a completed study report by year-end. The two Phase III trials upon which the lorcaserin NDA was based -- BLOSSOM and BLOOM -- excluded patients with Type II diabetes.

FDA also asked for information related to the increased rate of mammary tumors in female rats exposed to the serotonin (5-HT2C) receptor agonist, including a re-adjudication of all mammary and lung tissues from all female rats. The letter also requested information related to lorcaserin-emergent mammary adenocarcinoma and brain astrocytoma. FDA added that if evidence cannot be provided to alleviate concern about tumor findings in rats, additional clinical studies may be required. ...