Zevra’s Arimoclomol US FDA Panel Nod Includes Nonclinical Data Doubts

 
• By Sue Sutter

The pivotal trial results, along with other data, support a conclusion of efficacy for Niemann-Pick disease type C, but nonclinical data are weak and cannot serve as confirmatory evidence for a single trial, the advisory committee majority said.

Confirm
Zevra's nonclinical data cannot provide confirmatory evidence. • Source: Shutterstock

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