NEWS
Biohaven Achieves Positive Topline Results in Pivotal Study of Troriluzole in Spinocerebellar Ataxia (SCA)
• Troriluzole 200 mg dosed orally, once daily, in patients with SCA met the study's primary endpoint on the change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes.
◦ Troriluzole also showed statistically significant superiority after both 1 and 2 years of treatment.
• Troriluzole achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints.
• SCA patients treated with troriluzole showed a 50-70% slowing of disease progression, representing 1.5-2.2 years delay in disease progression over the 3-year study period.
• Biohaven plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for troriluzole in the treatment of all SCA genotypes in 4Q 2024. The application is eligible for a priority review given orphan drug and fast-track designations previously granted by FDA.
• Conference call and webcast to be held today at 8:30am ET
◦ Troriluzole also showed statistically significant superiority after both 1 and 2 years of treatment.
• Troriluzole achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints.
• SCA patients treated with troriluzole showed a 50-70% slowing of disease progression, representing 1.5-2.2 years delay in disease progression over the 3-year study period.
• Biohaven plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for troriluzole in the treatment of all SCA genotypes in 4Q 2024. The application is eligible for a priority review given orphan drug and fast-track designations previously granted by FDA.
• Conference call and webcast to be held today at 8:30am ET
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