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Biohaven Gets FDA May Proceed Letter For Phase 3 Trial Of BHV-3241 For MSA

Biohaven Pharmaceutical Holding Company Ltd. (BHVN) announced the U.S. Food and Drug Administration has notified the Company that it may proceed with its clinical investigation of BHV-3241, a novel myeloperoxidase or MPO inhibitor, which Biohaven is developing as a potential treatment for multiple system atrophy or MSA.

The FDA May Proceed Letter was received following Biohaven's reactivation of the investigational new drug (IND) application initially filed by AstraZeneca prior to licensing the compound to Biohaven.

BHV-3241 is a potential first-in-class, oral, brain-penetrant, irreversible inhibitor of MPO, an enzyme that acts as a key driver of pathological oxidative stress and inflammation in the brain. MPO inhibition is a promising therapeutic strategy for treating a number of neurodegenerative diseases, including MSA.

MSA is a rare, rapidly progressive, and fatal neurodegenerative disease that leads to death after an average of 6 to 10 years from disease onset. MSA causes Parkinson's disease-like movement problems (e.g., slow movement, rigid muscles, tremor, and poor balance), cerebellar ataxia, as well as problems with involuntary (autonomic) functions, including blood pressure control, bladder function, and digestion.

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