By Colin Kellaher
Biohaven has won Food and Drug Administration priority review for its application seeking approval of troriluzole for adults with spinocerebellar ataxia, a group of rare, genetic neurological disorders.
Biohaven on Tuesday said a green light would make troriluzole the first and only FDA-approved treatment for the life-threatening disorder.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Biohaven, a New Haven, Conn., biopharmaceutical company, said it expects an FDA decision in the third quarter, adding that it is prepared to commercialize troriluzole in the U.S. this year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 11, 2025 07:51 ET (12:51 GMT)
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