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.