LEQEMBI ® (lecanemab-irmb) Now Approved Via Traditional U.S FDA Review

Returning guest, Dr. Michael Irizarry, Senior Vice President and Deputy Chief Clinical Officer, Alzheimer’s Disease and Brain Health, at Eisai Inc. discusses the U.S. Food and Drug Administration’s (FDA) traditional approval of LEQEMBI ® (lecanemab-irmb) 100 mg/mL injection for intravenous use as the first and only disease-modifying treatment for Alzheimer’s disease (AD).

Dr. Irizarry joined Eisai in September 2018 as Vice President of Clinical Research, Epilepsy/Sleep, in which he led the clinical development of Eisai’s Epilepsy and Sleep/Wake programs, including regulatory submissions for compounds that received regulatory approvals to treat epilepsy and insomnia. He was named Vice President of Clinical Research for the Neurology Business Group in May 2019, and soon promoted to his current dual role in April 2020.

Prior to joining Eisai, Dr. Irizarry served as Vice President, Early Clinical Development, Neurosciences at Eli Lilly, responsible for the Phase 1 and 2 neurosciences portfolio. His focus was on neurodegeneration advancing molecules from candidate selection to investigational new drug applications, up through proof of concept studies. Before joining Eli Lilly, he was Acting Vice President, World-Wide Epidemiology at GlaxoSmithKline, where his team of more than 60 epidemiologists and database analysts supported clinical trial planning; safety and effectiveness studies; and oversight and application of in-house claim databases and electronic health records.

Dr. Irizarry earned undergraduate and medical degrees from Georgetown University, and a Masters of Public Health (M.P.H.) degree from the Harvard School of Public Health. He completed his neurology residency and Memory Disorders Fellowship at Massachusetts General Hospital, and continued as a member of the Harvard Medical School faculty at the Massachusetts Alzheimer’s Disease Research Center. His research has encompassed molecular mechanisms, clinical-pathological correlations, animal models, biomarkers, and epidemiology of neurodegenerative diseases, especially Alzheimer’s disease.

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