Special Episode: Lecanemab Approved for Alzheimer Disease
Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Sharon Cohen, MD, FRCPC. [LISTEN TIME: 14 minutes]
A special episode of the NeurologyLive®
The Mind Moments® podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.
This episode, "Lecanemab Approved for Alzheimer Disease," features an exclusive interview with 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 lecanemab. Similar to its predecessor, 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), which is anticipated to serve as supplementary data and is pending review by the FDA.1
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
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
Check out this NeurologyLive® Peers Exchange series, featuring Marwan Sabbagh, MD;
Alireza Atri, MD, PhD; Sharon Cohen, MD, FRCPC; and Eric McDade, DO.
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