Special Episode: Lecanemab Approved for Alzheimer Disease
Jan 09, 2023, 08:00 PM
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.
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 of NeurologyLive®'s coverage of lecanemab's approval, head here: FDA Approves Eisai’s Lecanemab for the Treatment for Alzheimer Disease
For more coverage of Alzheimer disease and dementia, head to NeurologyLive®'s Alzheimer & Dementia clinical focus page.
Episode Breakdown:
Episode Breakdown:
- 0:30 – Lecanemab (Leqembi; Eisai) approved for Alzheimer disease
- 1:35 – Sharon Cohen, MD, FRCPC, on the approval
- 3:15 – Supporting context on the accelerated approval pathway for lecanemab
- 4:50 – Questions about access amid current CMS guidance
- 6:25 – Data from the supporting phase 2 study, Study 201
- 7:15 – Safety and the 3 patient deaths reported in the clinical trial program
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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