Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab
US FDA’s Peter Stein says drug’s mechanism of action is relevant to all stages of Alzheimer’s disease. While clinical trials enrolled only those with mild disease as indicated on a PET scan, labeling has no limitations on use of Aduhelm. An FDA advisory committee member resigns from the panel in response to the approval.
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Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
A survey of advisory committee members finds many believe that an overwhelmingly negative vote should prevent a product approval.
Some big pharma R&D leaders have signaled enhanced interest in neuroscience R&D – and Alzheimer's more specifically – following FDA's approval of Biogen's Aduhelm based on biomarkers.