Posted by Michael Wonder on 15 May 2025
FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved.
Biohaven today announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the Company that they are extending the PDUFA date for the troriluzole new drug application for the treatment of spinocerebellar ataxia by three months to provide time for a full review of Biohaven's recent submissions related to information requests from the FDA.
