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

<p>This week, the US Food and Drug Administration <a href="https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease">approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease</a> using an accelerated approval pathway.</p><p>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 <a href="https://www.nbcnews.com/health/health-news/two-members-fda-panel-resign-protest-over-alzheimer-s-drug-n1270300">resigned in protest</a> over the drug's approval.</p><p>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."</p><p>But there <a href="https://www.cnn.com/2021/06/09/health/aducanumab-questions-answered-wellness/index.html">remain concerns about the drug's side effects</a> in addition to its price tag.</p><p><em>Health Affairs' </em>Senior Editor Leslie Erdelack joins Deputy Editor for Special Content Rob Lott on this episode of <em>Health Affairs This Week </em>to discuss the approval and review outstanding questions, drug pricing, and whether pharmaceutical companies might look to old data for new drug approvals.  </p><p><strong>Related Links:</strong></p><ul> <li> <a href="https://www.healthaffairs.org/do/10.1377/hblog20210609.921363/full/">The FDA's Approval of Aduhelm: Potential Implications Across A Wide Range Of Health Policy Issues and Stakeholders</a> (<em>Health Affairs Blog</em>)</li> <li> <a href="https://www.healthaffairs.org/do/10.1377/hblog20210604.489197/full/">Limiting Coverage Based On Efficacy And Safety: A Path For Medicare Regarding The Alzheimer's Treatment Aducanumab</a> (<em>Health Affairs Blog</em>)</li> <li> <a href="https://www.healthaffairs.org/doi/10.