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US FDA Staff Shoots Down Pfizer Inc Rare Disease Drug-Reuters


Tuesday, 22 May 2012 10:32am EDT 

Reuters reported that U.S. drug reviewers on Tuesday recommended rejecting a Pfizer Inc drug because the data did not prove it worked well in treating a rare neurodegenerative disease. The U.S. Food and Drug Administration staff reviewed the pill, tafamidis, ahead of an advisory panel of outside experts, which on Thursday will vote on whether to recommend it for approval. The FDA will make a final decision later, taking into account the panel's recommendation. Tafamidis, which is already approved in Europe under the name Vyndaqel, is meant to treat familial amyloid polyneuropathy, a fatal condition that affects as many as 10,000 people worldwide, including about 2,500 Americans. Two FDA reviewers said during a clinical trial that tafamidis was most successful in treating people in Portugal, but it was unclear why, and the data did not prove it helped those with the disease in other locations. People taking tafamidis during clinical trials also appeared to have a milder disease than those taking a placebo, which could skew the results, they said. The director of the FDA's division of neurology products, Dr. Russell Katz, emphasized the FDA had not yet made a final decision on tafamidis and wanted to get advice from the committee on Thursday. 

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