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Breaking News: The FDA Approves the BLA Submission for AMT-130 through the FDA Accelerated Approval Pathway
A statement from our CEO, Katie Jackson: “Today marks a turning point in medical history for HD in the United States, as the approval of the BLA submission through the accelerated approval pathway for AMT-130 for Huntington’s disease transforms hope into tangible progress—proving that urgency and innovation can rewrite the future for patients and families. I have had the honor of working on projects with the FDA since 2014. The one thing I have learned over the years is that the partnership between the FDA, the trial sponsors, and the HD community is the only one that will help expedite drug development and get products over the finish line. I am so thankful to the clinical trial participants more than anyone else for making the brave decision to participate in a clinical trial, to the 51,000 people who signed the petitions, uniQure for fighting through, and the FDA that listened to us and utilized regulatory flexibility through one of their promising pathways to get this to the next step. We are truly grateful. Today is a historic day, and I am so thankful to uniQure and the FDA for allowing me to be a part of it. This milestone proves that when science and determination unite, we can bring light to even the darkest of battles and offer new possibilities for generations to come.”
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