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

Health Affairs This Week

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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