Acorda Therapeutics Inc.'s risky regulatory strategy paid off at FDA, but it also has ramifications in the commercial world. As of September 30, seven months after Ampyra (dalfampridine) launched on March 1, the drug had generated sales of more than $85 million, well above the company's forecasts and most Wall Street analysts' expectations. But given the novelty of the drug and its clinical endpoints, its launch has also presented challenges. FDA approved Ampyra despite a mixed Advisory Committee reaction, and what some perceive to be poorly defined clinical endpoints, questionable responder rates, and a safety risk of seizures. As a result, doctors, payors, and patients must be educated about the science behind Ampyra. Some wonder if its stellar launch trajectory can continue, given what they perceive to be the drug's low efficacy for most people and lack of data correlating walking speed and improved quality of life or functionality. Furthermore, in the increasingly pressurized environment of reimbursement, payors are reviewing evidence on their own and may not come to the same conclusions as FDA.
By Wendy Diller
Acorda Therapeutics Inc.'s risky regulatory strategy paid off at FDA, but it also has ramifications in the commercial world....
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