Biohaven (BHVN) said Tuesday the Food and Drug Administration accepted for priority review its new drug application for troriluzole to treat adult patients with spinocerebellar ataxia.
The FDA is expected to decide on the application within six months, Biohaven said, adding that if approved it is prepared to commercialize troriluzole in the US in 2025.
The application submission is based on positive results from a study that showed that oral 200 mg doses of troriluzole met key endpoints of change from baseline in the functional scale for assessing the disease.
Biohaven shares were more than 7% higher in premarket trading.
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