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news.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).
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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.