May 17, 2017

FDA fast-tracks Biohaven drug

New Haven's Biohaven Pharmaceutical Holding Co. Ltd. said the U.S. Food and Drug Administration has granted the company Fast Track Designation for a drug to potentially treat Spinocerebellar Ataxia (SCA), a rare, debilitating neurodegenerative disorder estimated to affect about 22,000 people in the U.S.

The drug, trigriluzole, previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is conducting a Phase 2/3 clinical trial in SCA patients.

Standard care treatment for SCA is supportive and no medications are currently approved for patients with this debilitating condition, Biohaven said.

"This Fast Track Designation from the FDA recognizes the high unmet medical need in patients with SCA," said Dr. Vlad Coric, CEO of Biohaven. "Fast track designation will help facilitate Biohaven's development of trigriluzole, and potentially expedite future regulatory review of trigriluzole for patients with SCA."

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