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Pfizer's Genetic-Disease Drug Granted Priority Review By FDA

Drug maker Pfizer Inc. (PFE) said Wednesday that the U.S. Food and Drug Administration has agreed to a priority review of the company's new drug application or NDA for tafamidis meglumine, an experimental drug to treat a rare genetic disease known as Transthyretin Familial Amyloid Polyneuropathy or TTR-FAP.

TTR-FAP is a progressively fatal genetic neuro-degenerative disease caused by the mutation of the TTR gene. The disease affects about 8,000 patients worldwide.

TTR is a protein secreted by the liver and Pfizer's prospective drug destabilizes the proteins that form amyloid fibrils in the peripheral and autonomic nerves, as well as other organs including the gastrointestinal tract, kidneys and heart.

Pfizer noted that the FDA expects to complete the fast-track review of the drug by June 2012. The European Commission approved tafamidis in November 2011. The drug's trade name in the European Union is Vyndaqel.

Pfizer acquired tafamidis with its purchase of FoldRx Pharmaceuticals, a privately-held drug discovery and clinical development company, in September 2010.

Pfizer has earlier filed an application for the drug with the FDA in February 2011. However, the FDA wrote back to the company in April 2011 about its refusal to file the application, saying that the application was not sufficiently complete to permit a substantive review.

In general, refusal to file is reserved for applications with defects that make the application plainly inadequate or non-reviewable without major repair. An inadequate application may delay the process and may need several cycles of FDA response, letters, meetings and more start up time.

In Wednesday's session, PFE is trading at $21.16, down $0.17 or 0.82 percent on a volume of 4.71 million shares.

by RTT Staff Writer

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