U.S. FDA accepts Pfizer's tafamidis NDA for treatment of TTR-FAP

Feb 16 2012

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP). TTR-FAP is a rare, progressive and fatal neurodegenerative disease that affects approximately 8,000 patients worldwide. The European Commission approved tafamidis (the trade name in the European Union is VYNDAQEL^®) in November 2011.

The FDA has granted the tafamidis NDA a priority-review designation and has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in June 2012. Priority-review designation is granted to drugs that have the potential to offer significant improvement in treatment or provide a treatment where no adequate therapy exists.