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.

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Key Concepts

1. Aducanumab (Aduhelm) is a monoclonal antibody proven to reduce beta amyloid plaques in patients with Alzheimer’s disease.
2. 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).
3. 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.
4. 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.

References

• 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