NEW HAVEN, Conn., July 31, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN; "Biohaven") announced today that it received orphan medicinal product designation from the European Commission (EC) for taldefgrobep alfa, a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy (SMA). Orphan Designation highlights the potential for taldefgrobep to deliver significant benefit for people with SMA and provides regulatory and commercial incentives including a reduction in regulatory fees associated with protocol reviews and scientific advice, along with an additional ten-years of market protection. Biohaven previously received fast track and orphan drug designation from the FDA for taldefgrobep in the treatment of SMA.
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