In March, Biohaven shared that they have taken the decision to withdraw their new drug application to the European Medicines Agency (EMA) for Troriluzole to treat adults with all Spinocerebellar ataxia (SCAs). The EMA’s Committee for Medicines Products for Human Use (CHMP) said there was insufficient evidence provided to support the new active status for Troriluzole.
We understand that this will be disappointing news for the ataxia community. However, Biohaven said they plan to provide the required data, and remain committed to the development of Troriluzole for people with SCA.
Biohaven have also shared an update on their application to the US drug regulator, the FDA, stating that the deadline for the FDA to make a decision on whether to approve Troriluzole for SCAs in the US has been extended by three months. This is to provide time for a full review of Biohaven’s recent submissions related to information requests from the FDA. Biohaven therefore expect a decision from the FDA by Q4 2025. Read more here.
Read the letter from Biohaven to the EMA here.
