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Efficacy Voted Down; Surrogate Endpoint OK'd

AdComm Offers Split Opinion in Vyndaqel Single Study

By Marie Powers
Staff Writer

Friday, May 25, 2012

Members of the FDA's Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee delivered a split opinion Thursday on the use of a single study by sponsor Pfizer Inc., which is seeking approval for Vyndaqel (tafamidis meglumine) in the orphan indication transthyretin (TTR) familial amyloid polyneuropathy (FAP).

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