FDA advisory committee votes in favor of Pfizer's tafamidis meglumine

Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer's clinical data package for tafamidis meglumine. Tafamidis is a novel, investigational, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment. The Advisory Committee did not find substantial evidence of efficacy on a clinical endpoint. The Committee then voted 13-4 that the data provide substantial evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. This recommendation will be taken into consideration by the FDA when making its decision on Pfizer's New Drug Application (NDA) for tafamidis as a treatment for TTR-FAP, a rare and fatal neurodegenerative disease.    

"TTR-FAP is an irreversible and devastating disease with no FDA-approved treatment in the U.S.," said Dr. Yvonne Greenstreet, senior vice president and head of Medicines Development Group for Pfizer's Specialty Care Business Unit. "The panel's assessment represents a positive step forward in our goal to provide this much-needed medicine to patients suffering from this rare and fatal disease. Pfizer will continue to work with the FDA as the Agency finalizes its review of our NDA for tafamidis."    

Source:

Pfizer Inc.

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