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HelixTalk Episode #139 - They Did What?! FDA Approval of Aducanumab for Alzheimer’s Disease
Date posted: November 16, 2021, 6:00 am
In this episode, we discuss the recent accelerated approval of the new monoclonal antibody-based treatment agent, aducanumab (Aduhelm), by the FDA. We dive into the drug approval process, the efficacy and safety data, and the behind-the-scenes story of the FDA approval. Furthermore, we will present the controversy behind the approval and what it means for stakeholders.
- Aducanumab (Aduhelm) is a monoclonal antibody proven to reduce beta amyloid plaques in patients with Alzheimer’s disease.
- Despite reducing plaques, aducanumab did NOT result in meaningful cognitive improvements in patients receiving the drugs versus placebo; additionally, the drug was associated with a potentially concerning adverse effect called ARIA-E (amyloid related imaging abnormalities-edema).
- Despite an advisory panel unanimously recommending AGAINST approval and a lack of clinical outcome improvement, the FDA did go on to approve the drug in patients with Alzheimer’s disease using an accelerated approval process.
- In the episode, we discuss the substantial ramifications of the FDA’s approval primarily in hurting its credibility in validating the safety and efficacy of other medications on the US market.
- Adhulem approval package and FDA application files. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000TOC.cfm
- November 2020 Peripheral and Central Nervous System Drugs Advisory Committee Meeting files. https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2020-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting#event-materials