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FDA staff shoots down Pfizer rare disease drug

2012-5-23 09:51 

(Reuters) - 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.

WASHINGTON | Tue May 22, 2012 10:35am EDT



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