1. Pink Sheet

Will Advisory Committee Review Vindicate Pfizer’s Vyndaqel?

 
• By Mary Jo Laffler

Pfizer’s orphan drug tafamidis will be reviewed by FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in May. The scheduling of a panel during a priority review is some indication FDA has concern, but the panels of outside experts are generally receptive to rare disease treatments.

Pfizer Inc.will face another test of its rare disease group when its transthyretin familial amyloid polyneuropathy drug Vyndaqel (tafamadis meglumine) goes before FDA’s Peripheral and Central Nervous System Drugs Advisory Committee May 24.

FDA officials have repeatedly noted the difficulty of holding an advisory committee review in the tight timeframe of a six-month...

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