By Gayatri Dhir
Photo by Robina Weermeijer on Unsplash
Alzheimer’s, one of the most detrimental degenerative diseases, is incurable. Although it affects more than 6 million Americans each year, once diagnosed, there was nothing that doctors could do - the final stages of severe memory loss was inevitable (Belluck, 2023). This was the case until 2022, when Eisai, a Japanese pharmaceutical company, showed promising results in its clinical trials. Lecanemaeb, sold under the brand name Leqembi, was given accelerated approval by the FDA to: a) finish it’s clinical trials, and b) start selling this drug on the market. Naturally, it seems like everything was going fine - especially in January of 2023, where Leqembi got approved by the FDA, and went out to the public. However, Leqembi isn’t that simple of a drug, and to understand that, we need to look at (almost) everything about Alzheimer’s from the beginning.
Dementia has always been part of history. Early on, the ancient Egyptians and Greeks knew that there was some sort of degenerative disease which caused memory loss - but its cause was largely attributed to it as a natural occurrence as we age. This was it - in fact, no tangible developments in the disease itself were made until 1906. At the 37th Meeting of South-West German Psychiatrists, Alois Alzheimer, a clinical psychiatrist, reported a “peculiar severe disease process of the cerebral cortex” (Hippius and Neundörfer, 2003). Characterized with memory loss, insomnia, mania, and hallucination, the patient showed a “thinning of the cerebral cortex” - the section that is responsible for the higher level processes of the brain (eg. memory, personality, and learning). This was eventually identified as Alzheimer’s - where the brain would eventually shrink with the death of cells. Later on, it was found that specific proteins naturally found in the brain (eg. beta amyloid 42), would clump together in an Alzheimer’s affected brain, forming plaques that literally tangle neurons together (Smith, 2019). Interfering with the cell’s ability to transmit messages, severe cognitive decline was observed due to these tangles in the brain (National Institute on Aging, 2023).
Which brings us to Leqembi in 2022, the drug that has been marketed as one of the best and only “cures” of Alzheimer’s we have. In short, Leqembi is an antibody that binds itself to a protein in the brain that excessively grows during Alzheimer’s, amyloid beta (Gleckman, 2023). By doing so, the antibody helps the body destroy the proteins. In the clinical trials that followed nearly 1,800 participants over 18 months, patients that took the drug presented as having a “moderately less decline on measures of cognition and function”(Hamilton, 2023). This is a landmark discovery for individuals with early-stage Alzheimers, where the disease is detected 20-25 years prior - in fact, early-stage Alzheimer’s is widespread, affecting 1.5 out of the 6 million people that are diagnosed in the US each year (Belluck, 2023) . Joy Snider, professor of neurology at Washington University School of Medicine states that Leqembi’s ability to alleviate memory loss can have marginal effects: “Maybe you could keep driving for an extra six months of a year, maybe you could keep doing your checkbook for an extra six months to a year” (Snider, 2023).
However, it is vital to recognize the potential drawbacks this drug may have - both medically, and financially. Pharmaceutical companies Eisai and Biogen have decided that they will price Leqembi at $26,500 per year, which is extremely cost-ineffective. David Rind, chief medical officer for the Institute for Clinical and Economic Review states that “based on [their] draft results, [the] price [of Leqembi] would not meet typical cost-effectiveness thresholds” (Belluck, 2023). Given the large number of patients with Alzheimer’s, therapeutic drugs must be somewhat affordable for low-income patients - and it seems that Eisai won’t adjust their pricing model. Furthermore, Leqembi was given accelerated approval from the FDA - which means that they were not required to submit their Phase III trials due to their promising results from Phase II. However, from those specific Phase III trials, three individuals who took the drug died from adverse effects, such as brain bleeds and swelling; furthermore, 12.6% of individuals had brain bleeds as well (University of Rochester Medical Center, 2022). Dr. Alberto Espay, neurologist at the University Cincinnati College of Medicine describes that “because Eisai's Phase 3 trial only was for 18 months, it's unclear how prevalent the condition may be, or if it becomes more common the longer a person takes the drug.” (Lovelace, 2023).
The release of this new drug is promising - however, there are still hundreds of questions that arise, especially on the efficacy of the drug. As Leqembi begins to take effect, no one knows how helpful it will be to patients and their memories, or if it will help Alzheimer’s in higher stages. However, it’s important to recognize that Leqembi is a stepping stone to further advancements in the disease - which can finally help people live their lives to the fullest.
References
Belluck, P. (2023, January 6). FDA Approves, Leqembi, New Treatment for Early Alzheimer’s. The New York Times. https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html
Lovelace, B. (2023, January 18). 3 unanswered questions about the newly approved Alzheimer’s drug Leqembi. NBC News. https://www.nbcnews.com/health/aging/3-unanswered-questions-newly-approved-alzheimers-drug-leqembi-rcna66121
Gleckman, H. (2023, January 9). The FDA approved the new anti-alzheimer’s drug leqembi. What you need to know. Forbes. https://www.forbes.com/sites/howardgleckman/2023/01/09/the-fda-approved-the-new-anti-alzheimers-drug-leqembi-what-you-need-to-know/?sh=1ef4ac0a458b
Hamilton, J. (2023, January 6). FDA approves Alzheimer’s drug that appears to modestly slow disease. NPR. https://www.npr.org/sections/health-shots/2023/01/06/1147513068/fda-alzheimers-drug-leqembi-lecanemab-accelerated-approval
Hippius, H., & Neundörfer, G. (2003). The discovery of Alzheimer’s disease. Dialogues in Clinical Neuroscience, 5(1). https://doi.org/10.31887/DCNS.2003.5.1/hhippius
Smith, Y. (2015, December 10). Alzheimer’s tangles and plaques: What’s the difference? News-Medical.Net. https://www.news-medical.net/health/Alzheimers-tangles-and-plaques-whats-the-difference.aspx
What Happens to the Brain in Alzheimer’s Disease? (2019a). National Institute on Aging. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease
What You Need to Know about Lecanemab, the Potential New Alzheimer’s Drug. (2022, December 5). URMC Newsroom. https://www.urmc.rochester.edu/news/story/what-you-need-to-know-about-lecanemab-the-potential-new-alzheimers-drug
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