Biohaven is a pharmaceutical company developing Troriluzole as a treatment for SCA3.
In May 2023, Biohaven submitted a New Drug Application (NDA) to the US regulators (the FDA), to apply for approval of Troriluzole to treat SCA3. Unfortunately, the FDA have decided not to review the NDA, as the primary endpoint for the study was not met. The FDA indicated that Biohaven may request a meeting to discuss the concerns of the FDA.
In their press release, Biohaven state that they are committed to working with the FDA to bring Troriluzole to people with SCA3, and will request a meeting with the FDA.
Read the full press release here.
