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One Difference Between Amylyx’s ALS Drug And Aduhelm: A Biomarker Endpoint

Executive Summary

US FDA’s Billy Dunn says that if the drug had shown a positive effect on plasma neurofilament heavy chain, it ‘would have provided important contextual and supportive information of an ostensibly beneficial effect on the clinical measure.’

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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.

For Amylyx AMX0035 Panel Review, US FDA Relied Heavily on Temporary Voting Members

Peripheral and Central Nervous System Drugs Advisory Committee has held two of FDA’s most closely watched meetings in recent years, but there was little overlap between the panel that reviewed Amylyx’s ALS drug and the one that evaluated Biogen’s aducanumab 16 months earlier.

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