The Success of Lecanumab (Leqembi) in Treating Alzheimer's Disease

Author

Kathleen Warshawsky, BSN, RN

For more information about the author, click to view their website: Seniors Blue Book Greater Dallas

Posted on

Feb 06, 2023

Book/Edition

Non-Book Market , Texas - Dallas, Collin, SE Denton & Rockwall Counties

The Success of Lecanumab (Leqembi) in Treating Alzheimer's Disease

Alzheimer's disease is a debilitating and progressive brain disorder that affects more than 6.5 million Americans. It slowly erodes memory and thinking skills, and eventually the ability to carry out simple tasks. Despite the efforts of researchers and scientists, the specific causes of Alzheimer's disease are still not fully known. However, the disease is characterized by changes in the brain such as amyloid beta plaques and neurofibrillary tangles that result in the loss of neurons and their connections. These changes impact a person's ability to remember and think, leading to a decline in cognitive function.

Leqembi, also known as lecanemab-irmb, is a new treatment for Alzheimer's disease that as of January 6th, 2023, has been approved by the U.S. Food and Drug Administration (FDA) through the Accelerated Approval pathway. This new treatment represents an important advancement in the ongoing battle against Alzheimer's disease, as it targets the fundamental pathophysiology of the disease, rather than merely treating its symptoms.

Leqembi's efficacy was evaluated in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer's disease. The study showed that patients receiving the approved dose of Leqembi (10 milligrams/kilogram every two weeks) had a statistically significant reduction in brain amyloid plaque compared to the placebo arm. The amyloid beta plaque was quantified using positron emission tomography (PET) imaging, and was estimated in a composite of brain regions that are expected to be widely affected by Alzheimer's disease pathology.

The results of this study support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer's disease. The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIA) and a risk of infusion-related reactions. However, the most common side effects of Leqembi were infusion-related reactions, headache, and ARIA.

The FDA granted Leqembi Fast Track, Priority Review, and Breakthrough Therapy designations, highlighting the significance of this new treatment for Alzheimer's disease. Leqembi's approval marks a major milestone in the fight against Alzheimer's disease, providing hope for patients and their families who have been affected by this devastating condition.

Leqembi has been proven to be an effective treatment for Alzheimer's disease, offering a new hope for patients and their families. The results of the clinical trial demonstrate a significant reduction in brain amyloid plaque, a hallmark of Alzheimer's disease, and provide a strong foundation for further research and development in this field.

References:

·      U.S. Food and Drug Administration. (2023, January 6). FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. [Press Release]. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

·      Leqembi. (n.d.). Medication Guide. Retrieved from https://www.leqembi.com/-/media/Files/Leqembi/Medication-Guide.pdf?hash=d4e8f584-6cf3-41c4-a7f3-34bda6abb800


Author: Kathleen Warshawsky, BSN, RN | Publisher Seniors Blue Book Greater Dallas | https://www.linkedin.com/in/kathleenwbsnrn/


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