Updated with current stock price.
NEW YORK (TheStreet) — Last month, Arena Pharmaceuticals received a positive vote from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for the use of lorcaserin to treat obesity. The company did an admirable job parrying panelists’ questions and the FDA’s skepticism and earned an 18-to-4 recommendation for approval, with one abstention. On Wednesday, Arena faces its next hurdle: the Prescription Drug User Fee Act (PDUFA) date for lorcaserin, better known as the FDA’s approval decision date for the obesity drug.
Lorcaserin might receive final approval this week, but I think a three-month delay or another complete response letter (CRL) is more likely. As I have said in the past, I expect the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) to minimize inappropriate use of the drug and the risk of an unexpected safety debacle. (The sting of repeated obesity drug fiascos — American Home Products’ fenfluramine-phentermine, known as Fen-phen, and Abbott’s Meridia in the U.Ss, and Sanofi’s rimonabant in Europe — won’t go away any time soon.) Ultimately though, I think lorcaserin will be approved for sale in the US (and probably Europe, although a decision from European regulators won’t come until early-to-mid 2013). …
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