FDA to speed review of new Pfizer drug

Pfizer Inc. said today that the U.S. Food and Drug Administration has agreed to a priority review of the company’s new drug application for an experimental pill to treat Transthyretin Familial Amyloid Polyneuropathy, a rare neurodegenerative disease also known as TTR-FAP.

The pill, called tafamidis, already has received approval in the European Union for its ability to delay neurological impairment. The FDA has said its review should be completed no later than June of this year.

TTR-FAP is a fatal disease related to a genetic mutation.

Pfizer acquired tafamidis last year with the purchase of Massachusetts research company FoldRx Pharmaceuticals Inc. The FDA had previously denied an application for speeding up the drug-approval process because it said Pfizer did not submit enough information.

Much of Pfizer’s drug development work is performed at its laboratories in Groton, where the company’s largest contingent of scientists worldwide is located.