Pfizer Gets Complete Response Letter for Neuro Drug Vyndaqel

Pfizer has received a complete response letter from the FDA on its neuro drug Vyndaqel (tafamidis) after a negative advisory panel meeting, with agency staff and advisers raising concerns about the drug’s efficacy. The FDA requested a second study to establish substantial evidence of effectiveness prior to an approval, and also asked for additional information on the data Pfizer submitted with its NDA, Pfizer said.
Washington Drug Letter