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FDA Seeks More Data On Pfizer Inc Rare Disease Drug-Reuters


Monday, 18 Jun 2012 04:23pm EDT 

Reuters reported that U.S. health regulators declined to approve a Pfizer Inc's drug for a rare and fatal neurodegenerative disease until a second study can establish the effectiveness of the treatment. Pfizer said the Food and Drug Administration, in a so-called complete response letter, told the company it would not approve the drug, tafamidis meglumine, at this time. It asked for additional information on data already submitted to the agency and requested completion of a second efficacy study. The FDA decision to seek more information comes after agency reviewers, ahead of an advisory panel meeting of outside experts in May, recommended the drug's rejection, saying data had not proved that tafamidis worked well enough. The advisory panel then issued a split vote, saying that the drug failed to show it met the primary goal of a pivotal study, but that it was successful on another measure. 

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