Insights into FDA's controversial decision to approve a new Alzheimer's treatment drug

This week, the US Food and Drug Administration approved Aduhelm
(aducanumab) to treat patients with Alzheimer's disease using an
accelerated approval pathway.


The drug was approved on June 7, 2021, and the decision was quick
to spark controversy. At least two members of a panel of outside
advisors to the FDA from Mayo Clinic and Washington University
resigned in protest over the drug's approval.


Clinical trials for the drug, which is manufactured by Biogen,
showed a reduction in amyloid beta plaques. According to the FDA,
that is "a hallmark finding in the brain of patients with
Alzheimer's" and "is expected to lead to a reduction in the
clinical decline of this...form of dementia."


But there remain concerns about the drug's side effects in
addition to its price tag.


Health Affairs' Senior Editor Leslie Erdelack joins Deputy Editor
for Special Content Rob Lott on this episode of Health Affairs
This Week to discuss the approval and review outstanding
questions, drug pricing, and whether pharmaceutical companies
might look to old data for new drug approvals. 


Related Links:


The FDA's Approval of Aduhelm: Potential Implications Across
A Wide Range Of Health Policy Issues and Stakeholders (Health
Affairs Blog)

Limiting Coverage Based On Efficacy And Safety: A Path For
Medicare Regarding The Alzheimer's Treatment Aducanumab (Health
Affairs Blog)

The Search For Effective Alzheimer's Therapies: A Work In
Progress (Health Affairs)




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