FDA Issues Complete Response Letter for Arena's Lorcaserin
This article was originally published in The Pink Sheet Daily
Executive SummaryConcerrns Raised by Advisory Committee Come Back to Haunt Lorcaserin, the company's first product to go through regulatory process.
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Additional preclinical studies provided FDA with reassurance during a second-cycle review that lorcaserin was unlikely to trigger the valvular heart disease associated with dexfenfluramine and fenfluramine.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will revisit Arena’s obesity drug May 10; readjudication finds fewer cancers in rats than previously identified, but new data fails to rule out the 50% increased risk for valvulopathy sought by FDA.
Arena and Eisai expect to hear in the next week or so whether FDA will accept their answer to an October 2010 “complete response” letter and set a new action date for their novel weight loss drug.