FDA agrees to evaluate Troriluzole

The FDA has finally accepted Biohaven's new drug application (NDA) for Troriluzole, a drug that modulates the neurotransmitter glutamate, for the treatment of patients with spinocerebellar ataxia (SCA). The FDA is expected to announce its decision in the third quarter of this year, and if approved, Troriluzole will become the first SCA-specific treatment available on the U.S. market.

The troriluzole submission included data from study BHV4157-206-RWE (NCT06529146), as well as supplemental data from studies BHV4157-201 and BHV4157-206 (NCT03701399).

In parallel, Troriluzole is also being evaluated by the EMA for marketing in Europe.

For those who haven't had the opportunity to learn about Troriluzole, there is some information in this post https://www.ataxia.info/post/sobre-o-troriluzole