Pfizer Hasn't Proved Rare-Disease Drug Works, FDA Staff Says

Law360, New York (May 22, 2012, 1:40 PM EDT) -- Staff at the U.S. Food and Drug Administration on Tuesday said Pfizer Inc. has failed to prove the effectiveness of nerve disorder treatment Vyndaqel and recommended against approving the drug, potentially hampering the firm’s foray into the rare-disease market.

The agency’s feedback came in advance of a Thursday advisory committee meeting where a panel of outside experts will vote on whether the medicine should be cleared for sale.

Dr. Devanand Jillapalli, who analyzed clinical trial results submitted by Pfizer, concluded that there is “inadequate evidence of...
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