Reuters: Regulatory News: US FDA staff shoot down Pfizer rare disease drug

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US FDA staff shoot down Pfizer rare disease drug May 22nd 2012, 13:17 WASHINGTON | Tue May 22, 2012 9:17am EDT WASHINGTON May 22 (Reuters) - U.S. drug reviewers recommended on Tuesday 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 drug, tafamidis, ahead of an advisory panel of outside experts, which will vote on whether to recommend it for approval on Thursday. 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 about 8,000 people worldwide, according to Pfizer.

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