uniQure Agrees with FDA on Key Points of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
DENVER, Colo., Dec 10, 2024 (247marketnews.com)- uniQure (NASDAQ: QURE) reported that the company agrees with the U.S. Food and Drug Administration (FDA) on key elements of an AMT-130 Accelerated Approval pathway.
Walid Abi-Saab, M.D., uniQure’s chief medical officer, stated, “We are very pleased to reach agreement with the FDA on core components of an Accelerated Approval pathway for AMT-130. Our alignment reflects the strength of our data and collaborative discussions with the staff and senior management at FDA’s Center for Biologics Evaluation and Research (CBER). This is an important milestone for the Huntington’s disease community as it puts us on the most rapid and efficient pathway to deliver a potentially life-changing therapy to people living with this devastating neurodegenerative disorder. We have initiated BLA readiness activities and look forward to further engaging with the FDA in the first half of 2025 to discuss our statistical analysis plan and the technical CMC requirements.”
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