BioCentury
ARTICLE | Clinical News

Vyndaqel tafamidis meglumine regulatory update

June 25, 2012 7:00 AM UTC

FDA issued a complete response letter for an NDA for tafamidis meglumine from Pfizer 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. ...