FDA reviewing Pfizer's TTR amyloid cardiomyopathy therapy

Pfizer Inc. (NYSE:PFE) said FDA accepted for review two NDAs for tafamidis to treat transthyretin (TTR) amyloid cardiomyopathy based on two forms of the compound. The NDA for the tafamidis meglumine form was granted Priority Review with a PDUFA date of July, while the NDA for the free acid form is under standard review with a PDUFA date of November.

The company said the free acid form is bioequivalent to the meglumine salt form, and was developed for patient convenience to enable daily single capsule administration...