What Arena Pharmaceuticals Needs To Say To The May 10 FDA Advisory Committee
By Michael Murphy:Arena Pharmaceuticals (ARNA) will go before their second FDA Advisory Committee on May 10, seeking approval of lorcaserin for the treatment of obesity. Their PDUFA date for a final FDA decision is June 27. Recently, the FDA delayed the PDUFA date for Qnexa, another drug for obesity treatment made by Vivus (VVUS), to July 17. Because Arena has a manufacturing facility in Switzerland and a marketing partner in place for the U.S., they have an opportunity to be first to market with a new drug in this underserved sector. About one-third of adult Americans are obese, and the condition has serious, expensive consequences for the medical system including diabetes, heart disease and cancer. Qnexa is a combination of two approved generic drugs, an appetite suppressant, topiramate, with a metabolism increaser, phentermine. Topiramate was developed to treat epilepsy, and is often prescribed for migraine headaches. Phentermine is a 50-year-old drug currentlyComplete Story »
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