FDA Grants Priority Review for uniQure's Huntington's Disease Gene Therapy
The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) from uniQure for its gene therapy candidate, ifezuntirgene inilparvovec. The agency has granted Priority Review for the treatment, which is designed to target Huntington's disease. The FDA has set a decision action date of May 1, 2027, and is tentatively planning an advisory committee meeting to discuss the therapy. This regulatory milestone represents a significant step toward potential commercialization for uniQure's gene therapy platform.
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Topics: BLA Acceptance FDA Priority Review Gene Therapy Huntington's Disease
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