FDA Review of Biohaven's Troriluzole Will Take a Little Longer...

July 27, 2023

Pharmaceutical company Biohaven Ltd. announced today an update on the FDA approval process for its drug Troriluzole. According to Biohaven, the FDA declined to review its recently submitted application for approval due to initial results (objectives) that were not achieved during the clinical trial. The FDA informed Biohaven that it may request a Type A meeting within 30 days to discuss the matter. Biohaven states that it is committed to working with the FDA to obtain approval of Troriluzole for the benefit of patients with spinocerebellar ataxia type 3 (SCA3) as quickly as possible, given that there is currently no approved drug or therapy for this serious and ultra-rare genetic disease.

Original text: Pharma News, NAF (National Ataxia Foundation) https://www.ataxia.org/pharmanews/

[Post published on 07/27/2023 by Márcio Galvão]