Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab
Executive Summary
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.
You may also be interested in...
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy
She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.