FDA issues Complete Response Letter for tafamidis (Pfizer) for TTR-FAP

The FDA has issued a Complete Response Letter for the transthyretin familial amyloid polyneuropathy drug, tafamidis from Pfizer. The FDA has requested the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. Tafamidis was approved in the EU as an orphan drug with the name Vyndaqel.