FDA panel backs accelerated approval for tafamidis

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that surrogate endpoint data for tafamidis from Pfizer Inc. (NYSE:PFE) were robust enough to predict a clinical benefit in patients with transthyretin (TTR) familial amyloid polyneuropathy (FAP). The vote could pave the path for accelerated approval of the compound.

The panel backed the surrogate endpoints to support accelerated approval after voting 13-4 that the data on the clinical endpoints in the pivotal Phase II/III Fx-005 trial were not robust enough to support regular approval. ...