Written By: Dr. Raymond Larnyoh
Edited By: Kenneth Dandurand
Alzheimer's disease is a progressive form of dementia that causes memory loss, difficulty with thinking and problem-solving, and changes in mood and behavior. It is estimated that 6.2 million Americans aged 65 and older are currently living with Alzheimer's disease. According to the Center for Disease Control (CDC) Alzheimer is the seventh leading cause of death in the United States.
In January, the Food and Drug Administration (FDA)gave accelerated approval to a monoclonal antibody lecanemab, sold under the brand name Leqembi. The accelerated approval pathway is used to grant approval for drugs meant to treat a serious condition that help address an unmet medical need. These drugs are then reviewed for approval based on a specific biomarker, or biological indicator of disease. Lecanemab may offer hope to those affected with early mild cognitive impairment or dementia due to Alzheimer’s disease. Lecanemab, works by targeting a protein called beta-amyloid, a vital component of the plaques that form in the brains of patients with Alzheimer's disease. By reducing plaque formation lecanemab moderately slows the decline in early cognitive function in Alzheimer’s disease. A phase III clinical trial found a 27% reduction in functional and cognitive decline in the lecanemab group compared to placebo. Infusion related reaction occurred in 26.4% of patients and 12.6 % had inflammation, swelling in the brain with risk of bleeding.
Currently there are limited treatments for Alzheimer’s disease with most (donepezil (Aricept), memantine (Namenda) and rivastigmine patch (Exelon)), aimed at managing symptoms. Aducanumab (Aduhelm) received accelerated FDA approval in 2021 as the first monoclonal antibody treatment reducing plaque formation has shown limited clinical effectiveness in slowing the progression of Alzheimer's. It is only covered by Medicare as part of a clinical trial. Lecanemab is currently priced at $26,000 per year and administered by weight-based infusion every 2 weeks. It appears from the studies, lecanemab may bind stronger to the beta amyloid plaques significantly faster than aducanumab (Aduhelm). The Centers for Medicare & Medicaid Services is currently considering covering lecanemab for Medicare patients.
In conclusion, lecanemab is a promising monoclonal antibody approach to moderately slowing the progression of Alzheimer's disease. More research is necessary to fully understand the clinical benefits and limitations of this treatment in early mild to moderate Alzheimer's.
References:
Alzheimer's Disease Fact Sheet.” National Institute on Aging, National Institute on Aging, U.S. Department of Health and Human Services, Feb,2023, www.nia.nih.gov/health/alzheimers-disease-fact-sheet.
Full Prescribing Information. LEQEMBI [Package insert]. Biogen. 2023. Available at: https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf?hash=3d7bf1a2-5db2-4990-8388-81086f415676
FDA Grants Accelerated Approval for Alzheimer’s Drug. Jan 2023. News Release. Available from: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948
Alzheimer's disease: Experimental drug Lecanemab appears to slow .... https://edition.cnn.com/2022/11/29/health/lecanemab-alzheimers-drug-study/index.html
FDA approves Alzheimer’s drug Lecanemab amid safety concern. Jan 2023. Available from: https://www.nature.com/articles/d41586-023-00030-3
About the Author:
Raymond Larnyoh, PharmD
Pharmacy Practice Fellow for Clinical Pharmacy Associates
Dr. Raymond N Larnyoh, is a Pharmacy Practice Fellow for Clinical Pharmacy Associates. Dr. Larnyoh received his pre-pharmacy studies from Montgomery college with an associate in science and a focus on biology and chemistry. He received his Doctor of Pharmacy from the Northeast Ohio Medical University. During his pharmacy training, Dr. Larnyoh worked as a pharmacy intern at the University Hospital Portage Medical Center for over two years. Dr. Larnyoh also served as the pharmacy representative for diversity and inclusivity. Today Dr. Larnyoh is completing a fellowship with Clinical Pharmacy Associates as Pharmacy Practice Fellow.
Kenneth Dandurand, RPh, MS
Co-Founder and CEO of Clinical Pharmacy Associates, Inc. and Co-Founder and President of MedNovations, Inc. Board Member Asperger/Autism Network
Ken is an ASHP residency trained clinical pharmacist with a BS from Northeastern University and a Master’s from Oregon State University. As an entrepreneur and researcher for 35 years he co-founded Clinical Pharmacy Associates and MedNovations successful leaders in providing direct pharmaceutical care via tele-pharmacy. He is dedicated to improving the delivery of medication therapy management to consumers. To that end, Ken has authored a chapter in the Book “Misadventures in Health Care: Inside Stories” titled “Prescription for Error.”