logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Pfizer said Friday it reached a multi-year deal with Gilead Sciences to manufacture and supply Gilead's investigational antiviral remdesivir for COVID-19 patients. Ferring Pharmaceuticals US is recalling various nasal sprays citing superpotency or amounts of desmopressin higher than specified, the U.S. Food and Drug Administration announced in a statement. The recall involves all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL. U.S. President Donald Trump has issued executive orders to ban Chinese mobile application TikTok as well as WeChat, citing a threat to national security and its economy. China's ByteDance Ltd. owns TikTok, a video-sharing mobile app, while Tencent Holdings Ltd. owns WeChat, a messaging, social media, and electronic payment app.
RELATED NEWS
Follow RTT