Regulatory Affairs

FDA accepts Pfizer tafamidis meglumine new drug application

PBR Staff Writer Published 16 February 2012

The US Food and Drug Administration (FDA) has accepted Pfizer's new drug application (NDA) for tafamidis meglumine, an oral therapy for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP).

The European Commission approved tafamidis (the trade name in the European Union is VYNDAQEL) in November 2011, the company said.

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.

TTR-FAP is a rare, progressive and fatal neurodegenerative disease that affects approximately 8,000 patients worldwide.