The FDA has accepted an NDA resubmission for an oral spinocerebellar ataxia (SCA) drug from Biohaven, having previously issued a complete response letter (CRL) in November 2025.
SCA is a rare, neurodegenerative disease for which there is no current treatment. Vyglxia originally received Orphan and Fast Track designation, and the FDA accepted Biohaven's NDA with Priority Review, although it delayed the PDUFA date by three months during the review period. The FDA ultimately determined potential bias, design flaws, a lack of pre-specification, and unmeasured confounding variables in the clinical study, which resulted in the CRL.
The FDA has said that the resubmission is a complete response to the action letter. It has assigned a user fee goal date of the first quarter of 2027. It will also be obtaining input from external stakeholders through a meeting of the Peripheral and Central Nervous System Advisory Committee.