Positive Clinical Results for Alzheimer’s Amyloid-Clearing Drug – Lecanemab Poised for FDA Approval

Positive results from new amyloid-clearing drug represent a starting point for Alzheimer’s treatment, while combination therapy remains the holy grail.

Amyloid-clearing drug lecanemab will be a positive step in the treatment of Alzheimer’s disease based on study results presented at the 15^th Clinical Trials on Alzheimer’s Disease (CTAD) conference and published in The New England Journal of Medicine. Lecanemab is poised for FDA approval early next year. Alzheimer’s is a complex disease with multiple underlying causes tied to the biology of aging, therefore the Alzheimer’s Drug Discovery Foundation (ADDF) has long held that a combination drug approach is needed.

“Today’s results show that lecanemab slows cognitive decline, which is welcome news for the millions of patients and families living with Alzheimer’s,” said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the ADDF. “But this is only a start to stopping Alzheimer’s in its tracks. We have a lot of ground to cover to get from the 27% slowing lecanemab offers to our goal of slowing cognitive decline by 100%.”

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Amyloid-clearing drugs are one part of the solution, but there remains a pressing need to develop a new generation of drugs targeting all aspects of the biology of aging that can be combined to address the full array of underlying pathologies that contribute to the disease. New and emerging easy-to-use diagnostic tools like those supported by the ADDF’s Diagnostics Accelerator can help pinpoint the specific underlying causes of each person’s Alzheimer’s, enabling precision treatment approaches and improving clinical trials.

“Unique drug combinations matched to each patient’s underlying pathologies is the answer, and our best hope to give patients long-lasting relief from this insidious and progressive disease,” said Dr. Fillit.

Today’s Alzheimer’s drug pipeline is more robust than ever, with 75% of drugs currently in clinical trials aimed at novel targets beyond amyloid and tau according to a recent report.

“Today’s news is encouraging for everyone who has worked on lecanemab and for those of us who have spent decades tackling Alzheimer’s by improving clinical trial designs,” said Dr. Fillit. “But even more, this is proof that our research is paying off. It gives us a clear vision of a day soon when treatments will allow patients to maintain their independence not just for weeks or months more, but for years more and perhaps for their lifetimes

Reference: “Lecanemab in Early Alzheimer’s Disease” by Christopher H. van Dyck, M.D., Chad J. Swanson, Ph.D., Paul Aisen, M.D., Randall J. Bateman, M.D., Christopher Chen, B.M., B.Ch., Michelle Gee, Ph.D., Michio Kanekiyo, M.S., David Li, Ph.D., Larisa Reyderman, Ph.D., Sharon Cohen, M.D., Lutz Froelich, M.D., Ph.D., Sadao Katayama, M.D., Marwan Sabbagh, M.D., Bruno Vellas, M.D., David Watson, Psy.D., Shobha Dhadda, Ph.D., Michael Irizarry, M.D., Lynn D. Kramer, M.D., and Takeshi Iwatsubo, M.D., 29 November 2022, The New England Journal of Medicine.
DOI: 10.1056/NEJMoa2212948