Biohaven has received a complete response letter (CRL) from the FDA for its NDA for the once-daily pill, Vyglxia (troriluzole), which treats spinocerebellar ataxia (SCA).
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 NDA for Vyglxia included data from clinical trials showing that the drug slowed the progression of the genetic disease by between 50% and 70% compared to matched controls. It also showed that Vyglxia reduced the risk of falls and resulted in a delay in the loss of the ability to walk. However, the FDA has highlighted potential bias, design flaws, a lack of pre-specification, and unmeasured confounding variables in the clinical study.
Biohaven is currently restructuring to reduce its annual direct R&D spend by 60%. This may result in it pausing or delaying non-priority programs over the next year to allocate more resources to priority clinical-stage programs.