Biohaven has announced FDA approval for Troriluzole
Biohaven has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for troriluzole, a novel treatment for spinocerebellar ataxia (SCA), and granted it Priority Review status. This designation accelerates the review process, with a decision expected within six months. Read here.
Troriluzole has demonstrated promising results in clinical trials, showing a 50% to 70% reduction in disease progression over a three-year period. This translates to a delay in disease progression of approximately 1.5 to 2.2 years.
Spinocerebellar ataxia is a rare, neurodegenerative disorder characterized by progressive loss of coordination and balance. Currently, there are no FDA-approved treatments for SCA, underscoring the significance of troriluzole’s potential approval.
Biohaven plans to collaborate closely with the FDA throughout the review process, aiming for a potential launch of troriluzole in 2025.
The National Ataxia Foundation has been instrumental in supporting research and development efforts for SCA treatments, contributing to advancements like troriluzole. Read more about NAF here.
This development offers hope to the SCA community, bringing us closer to the first approved therapy for this challenging condition.