FDA rebuffs tafamidis, wants second trial

FDA issued a complete response letter for an NDA for tafamidis from Pfizer Inc. (NYSE:PFE) to treat transthyretin (TTR) familial amyloid polyneuropathy (FAP). According to Pfizer, the agency asked for a second efficacy study and additional information on data included in the NDA. Pfizer said it will work with the agency to address the letter's contents, but did not provide a timeline. ...