FDA Reacts To The Death Related To Experimental Antibody Therapy For Alzheimer's Disease

Dr. Adam Tabriz

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Immunotherapy is a form of biological intervention to fight a variety of diseases. This novel scientific breakthrough has been one of the significant frontlines of future therapeutic modalities.

Scientists today can moderate a patient's immune response (through suppression or stimulation) to fight various diseases. One of the most recent studies is on Alzheimer's Dementia, and that medication is called Lecanemab.

Lecanemab is an immune-modulating medication manufactured by BioArctic AB, Biogen, Eisai Co., Ltd under the brand Alzforum.

Although Lecanemab is yet to be commercially available, the preliminary clinical trials have demonstrated promising results. The new Alzheimer's Drug has been shown to slow down dementia progression in humans.

Despite recent impressive preliminary results, there have been a few events among the patient volunteers who signed up for the Lecanemab clinical trial. The incident has prompted Food And Drug Administration (FDA) to reevaluate whether the manufacturers should continue with the clinical trial.

On Wednesday, January 4, 2023, CNN reported on the sudden death of a Lecanemab clinical trial participant. The incident prompted FDA to place the continuation of the trial under consideration. Although the relationship between this event and the novel medication is still uncertain, their possible link must be determined to prevent future occurrences.

Alzheimer's disease is a form of dementia that is sporadic. Sixty to seventy percent of Alzheimer's cases typically happen among individuals over 65.

Research has revealed a distinct genetic basis related to the development of substances in brain cells Presenilin I and II through mutation. The latter substances are called Amyloid precursor proteins, which, if mutated, can lead to Alzheimer's disease at an earlier age.

Amyloids are collections of proteins in brain cells often detected in patients with Alzheimer's Dementia.

Lecanemab, a monoclonal antibody (IgG1) that binds with high affinity to Amyloid Beta (Aβ) soluble protofibrils, is being tested in persons with early Alzheimer's disease. The latter mechanism counteracts the other toxic substance in the brain cells and slows this debilitating disease's progress.

Alzheimer's dementia is a progressive disease, and all currently available therapies are supportive. Presently, treatments like Aricept and Exelon (Cholinesterase Inhibitors) have demonstrated limited effectiveness.

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Lecanemab is one of the first potential drugs that effectively slow cognitive decline among Alzheimer's patients. The experimental drug's potential has passed the phase III trial; however, it is yet to pass the safety test.

Indeed, safety concerns like brain swelling and bleeding associated with Lacanemab seem legitimate.

The recent deadly case reported by CNN was related to the point of a 65 y old who suffered from early-stage Alzheimer's Dementia. The individual presented to the Chicago-area hospital with signed of stroke and later passed due to a brain hemorrhage.

A recent publication by the New England Journal of Medicine suggests; despite the unquestionably promising efficacy of Lecanemab, still, longer trials are necessary to prove effectiveness and ensure safety. That is even more warranted, given the recently reported adverse reactions.

BioArctic AB, Biogen, Eisai Co., Ltd is expected to receive the FDA's decision within days.

References

  1. Anon., 2017. Lecanemab | ALZFORUM [online]. Lecanemab | ALZFORUM. Available from: https://www.alzforum.org/therapeutics/lecanemab [Accessed January 6, 2023].
  2. Sealy, J. C., Amanda, 2023. The report shares new details about death possibly linked to experimental Alzheimer's drug | CNN [online]. CNN. Available from: https://www.cnn.com/2023/01/04/health/lecanemab-trial-report/index.html [Accessed January 6, 2023].
  3. Howard, J., 2023. FDA decision on experimental Alzheimer's drug expected this week | CNN [online]. CNN. Available from: https://www.cnn.com/2023/01/02/health/lecanemab-fda-decision-expected/index.html [Accessed January 6, 2023].
  4. Anon., 2023. List of Cholinesterase inhibitors (acetylcholinesterase inhibitors) — Drugs.com [online]. Drugs.com. Available from: https://www.drugs.com/drug-class/cholinesterase-inhibitors.html [Accessed January 6, 2023].

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