The FDA has accepted Biohaven's resubmitted drug application for troriluzole (Vyglxia) to treat spinocerebellar ataxia, setting a Q1 2027 review deadline. The resubmission follows a November 2025 complete response letter citing concerns about real-world evidence methodology. An advisory committee is also planned to weigh in before any final decision.
The FDA has accepted Biohaven's resubmitted new drug application (NDA) for troriluzole (Vyglxia) for spinocerebellar ataxia (SCA) — a rare, progressive neurological disease — and set a user fee goal date in Q1 2027. The agency also plans to convene its Peripheral and Central Nervous System Advisory Committee before making a final call, though the meeting date hasn't been announced yet.
This resubmission comes after the FDA issued a complete response letter in November 2025, flagging concerns about the real-world evidence study underpinning the original application — specifically citing potential bias, design flaws, and unmeasured confounding in the externally controlled trial design. Biohaven says the resubmission includes new positive supportive analyses to address those concerns.
Key Takeaways:
Why it matters: SCA has no FDA-approved treatments, making troriluzole's path to approval closely watched by neurologists and patients alike. The advisory committee review adds another layer of scrutiny, but also signals the FDA is taking a thorough look at a disease area with significant unmet need.
