In September 2024 Biohaven announced positive results from their study of troriluzole to treat SCA 1, 2, 3, 6, 7, 8 and 10. Following these results they submitted a new drug application (NDA) for troriluzole for all types of SCAs to the US regulators, the FDA.
Unfortunately, on 5th November 2025 Biohaven announced, via a press release, that the FDA had issued a complete response letter to Biohaven informing them that they have not approved the NDA. The FDA have recommended that Biohaven meet with them to discuss the evidence that will be needed for Biohaven to re-submit an NDA in the future. Biohaven are requesting a meeting with the FDA as soon as possible to discuss potential next steps and state that they are committed to working with the FDA to achieve new drug approval of troriluzole.
Ataxia UK understands that this news will be disappointing for the SCA community. We will continue to do what we can to advance treatment development for the ataxias. We will continue our dialogue with Biohaven and provide further updates as soon as we can.
Please find the link to the press release here.
