Pfizer’s Vyndaqel Splits Advisory Committee; Now It Must Move FDA
This article was originally published in The Pink Sheet Daily
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.
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When Is A Single Pivotal Trial “Robust” Enough? FDA’s Katz Offers Examples That Could Spell Trouble For Pfizer’s Vyndaqel
The single pivotal trial of Pfizer’s Vyndaqel couldn’t offer p-values of less than 0.01, nor substantial evidence from multiple sites, which could spell trouble for the new drug application.