uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application
uniQure said Wednesday the U.S. Food and Drug Administration will let it use three-year data from its early Huntington’s gene therapy trial as the basis for an accelerated approval filing, changing course in the dragged-out regulatory battle over the therapy. The company will go ahead with a biologics license application in the third quarter. That application is the standard FDA process for marketing a biologic drug in the U.S.