Biohaven (BHVN) is jumping 10% after the FDA agreed to review the company’s potential treatment for a rare disease.
The FDA’s Decision on BHVN’s Drug Candidate
The FDA agreed to review BHVN’s application for the approval of its drug candidate, troriluzole, Biohaven announced today. Additionally, the agency decided to grant the drug Priority Review status. According to BHVN, Priority Review is granted to “drugs that would offer a significant improvement over other available treatments for a given disorder or would provide a treatment option where none exists.”
A laboratory technician in a safety suit analyzing and conducting a series of experiments.
Information on Troriluzole
Troriluzole is a potential treatment for a rare, genetic, neurodegenerative, life-threatening disease called spinocerebellar ataxia (SCA). There is currently no FDA-approved treatment for SCA, which results in “relentless and irreversible functional decline including impairments in coordination and balance leading to falls, loss of ambulation, and difficulties with vision, speech and swallowing,” according to BHVN.
In a three-year study, the rate of decline of patients taking troriluzole was 50%-70% slower than those in a control group. Moreover, the drug candidate met the study’s primary endpoint while demonstrating “statistically significant superiority across 9 consecutive, prespecified primary and secondary endpoints,” BHVN reported.
The company expects the FDA to make a decision on its application in the third quarter of this year.
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This article is originally published at Insider Monkey.
