Pfizer’s <em>Vyndaqel </em>Splits Advisory Committee; Now It Must Move FDA

Pfizer’s Vyndaqel Splits Advisory Committee; Now It Must Move FDA

24 May 2012

• By Martin Berman-Gorvine

In mirror-image votes, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee says that there is substantial evidence for surrogate endpoints but not for clinical endpoints for the drug to treat familial amyloid polyneuropathy.

More support for Pfizer Inc.’s orphan drug Vyndaqel (tafamidis meglumine) was to be found on FDA’s Peripheral and Central Nervous System Drugs Advisory Committee than might have been expected from the agency’s presentations and background materials questioning whether there was substantial evidence of efficacy against familial amyloid polyneuropathy (FAP).

In back-to-back votes during its May 24 meeting, the panel said by a 13-4 margin that the findings of the...