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FDA Rejects Pfizer Inc. (PFE)'s Drug for Rare Nerve Disease


6/19/2012 6:39:11 AM

Pfizer Inc. (PFE) (PFE), the world’s largest drugmaker, failed to win U.S. regulators’ approval of its drug to treat TTR-FAP, a rare and deadly genetic disorder affecting 8,000 people worldwide. The Food and Drug Administration asked for a second clinical trial showing the effectiveness of tafamidis meglumine, New York-based Pfizer said today in a statement. The pill would be the first approved treatment in the U.S. for TTR-FAP, or Transthyretin Familial Amyloid Polyneuropathy. TTR-FAP robs patients of the use of their limbs from the feet upwards, and as their digestive system turns against them, they waste away and die in about a decade. In Europe, the drug was approved in November for sale under the name Vyndaqel. Pfizer estimates there are 3,000 U.S. patients.

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