FDA to Review uniQure Huntington Therapy
The US Food and Drug Administration has accepted uniQure's application for its Huntington's disease gene therapy, with a decision expected by May 2027. The agency will review the treatment under its accelerated approval pathway using early- to mid-stage study results.
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The United States Food and Drug Administration accepted an application from UNIQURE NV for its Huntington's disease gene therapy, setting a decision deadline of May 1, 2027. The regulatory milestone follows a prior trial setback where the treatment failed to slow disease progression over four years. The review provides the Dutch biotechnology developer a pathway to accelerate commercialization for a therapy targeting a severe neurodegenerative disorder.
