Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In 2022 and onward, whenever the FDA makes a major decision for the field of neurology, we'll be releasing short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.



In this episode, we're covering the recent approval of lecanemab (Leqembi; Eisai) in Alzheimer disease. Offering commentary is Sharon Cohen, MD, FRCPC, a behavioral neurologist and medical director of the Toronto Memory Program at the University of Toronto, and a trial investigator for Clarity AD, the phase 3 trial of the antiamyloid agent. Lecanemab was approved via the accelerated approval pathway, with the application supported by data from the phase 2b proof-of-concept clinical trial, known as Study 201 (NCT01767311). The pivotal phase 3 Clarity AD trial (NCT03887455) is anticipated to serve as supplementary data and is pending review by the FDA.

For more coverage of Alzheimer disease and dementia, head to NeurologyLive®'s Alzheimer & Dementia clinical focus page.



Episode Breakdown:

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REFERENCES

1. FDA grants accelerated approval for Alzheimer's disease treatment. FDA. News release. January 6, 2023. Accessed January 9, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment