For those that missed Part One, a quick recap: In September 2010, an FDA panel of experts voted 9-5 to recommend against the approval of Arena's lorcaserin. Panel members were unimpressed with the drug's mediocre efficacy and concerned about several potential safety problems, most notably a risk that a high prevalence of rat tumors could raised the cancer risk in humans. FDA followed the panel's negative recommendation and rejected lorcaserin.
Part Two: Arena resubmits lorcaserin to FDA with new data aimed at satisfying lorcaserin safety issues regarding rat tumors and potential for heart-valve damage. Today, a second panel of experts will review these new lorcaserin data and once again vote on whether the drug should be recommended for approval, or not.Unlike 2010, Arena enters today's panel with what appears to be more support from FDA medical reviewers, which may help swing the vote in the drug's favor. FDA's approval decision date for lorcaserin is June 27. A similar FDA advisory panel in February voted 20-2 to recommend the approval of Vivus' obesity drug Qnexa. FDA's approval decision date is July 17. Follow all of today's action on this live blog, including the penultimate panel discussion and vote, which should come between 3 pm and 5 pm EDT. --Written by Adam Feuerstein in Boston.
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