Lecanemab Sets a New Bar in Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) granted Leqembi accelerated approval on Jan. 6, 2023. It is the seventh drug the FDA has approved for the treatment of Alzheimer’s disease.

The generic name of the drug is Lecanemab. It has been developed by the Japanese company Eisai in partnership with the U.S. company Biogen. These are the same companies that developed the sixth drug for the treatment of Alzheimer’s disease, Aduhelm (generic name aducanumab).

There are currently seven drugs approved by Food and Drug Administration (FDA) for the treatment, but there is no cure for Alzheimer’s disease despite all scientific efforts and many protracted and expensive clinical trials.

FDA-Approved Alzheimer’s Drugs

Aducanumab (Aduhelm®) was approved by the FDA in June 2021, and is the first approved Alzheimer’s disease drug to address the underlying cause of the disease rather than the symptoms.

The five other drugs are donepezil, rivastigmine, galantamine, memantine, and a combination of memantine with donepezil. These drugs can temporarily treat symptom, but cannot affect the underlying brain changes of Alzheimer’s disease or alter the course of the disease. Nonetheless, these five drugs have relatively mild side effects, such as headache and nausea.

Aduhelm is a human IgG1 anti-amyloid monoclonal antibody. It works to reduce amyloid beta, the main component of amyloid plaques. The treatment does not result in cognitive improvement in Alzheimer’s disease, and therefore is not an efficient treatment for the disease itself.

The sales of Aduhelm have been slow, largely because Medicare will only cover the drug for patients participating in a clinical trial.

In addition, aducanumab is associated with a 40 percent increased risk of a serious condition called amyloid-related imaging abnormalities (ARIA), an indicator of brain swelling. Individuals receiving aducanumab should be monitored closely so ARIA is quickly identified and safely managed.

Similar to aducanumab, lecanemab is a humanized IgG1 monoclonal antibody that binds with high affinity to amyloid beta soluble protofibrils; it is being tested in the clinic trial for persons with early Alzheimer’s disease.

Aducamumab and lecanemab are developed by the Japanese company Eisai along with the U.S. company Biogen. Lecanemab targets a soluble version of amyloid-beta, while Aduhelm binds to those plaques more strongly.

Moreover, lecanemab takes the first therapeutic intention to slow mental decline in a robust clinical trial.

A newly published multicenter, double-blind, phase 3 trial in The New England Journal of Medicine demonstrated that lecanemab can reduce the rate of cognitive decline by 27 percent after a 18-month clinical investigation on approximately 1,800 people in the early stages of Alzheimer’s disease.

The selected subjects with early-stage Alzheimer’s were administered with biweekly intravenous infusions of lecanemab, while the controls received a placebo for 18 months. The participants’ cognition performance was assessed primarily with a metric called the Clinical Dementia Rating–Sum of Boxes (CDR-SB).

The results showed that 59.1 percent participants had brain amyloid reduction; 44 percent of them have cognition improvement on the CDR-SB evaluation scores, and the average daily living (ADL) level increased double.

Side Effects

Though the first five Alzheimer’s drugs that the FDA approved could not fundamentally reduce the pathological changes of Alzheimer’s disease, they have relatively mild side effects, such as headache and nausea.

However, aducanumab is associated with a 40 percent increased risk of a serious condition called amyloid-related imaging abnormalities (ARIA), an indicator of brain swelling. Individuals receiving aducanumab should be monitored closely, so ARIA is quickly identified and safely managed.

In a study of Lecanemab, 20 percent of participants experienced an adverse event, such as swelling or bleeding in the brain, with symptoms of headaches, visual disturbances, and confusion.

So far, the treatment with Lecanemab during clinical trials has also been linked to three deaths.

One individual suffered a stroke before the treatment and received a blood thinner before receiving Lecanemab. A second death occurred when a woman suffered stroke symptoms after starting Lecanemab treatment, followed by a series of seizures; she died a few days later, and her doctor found massive bleeding in her brain.

On Jan. 4, 2023, two days before the US FDA approved the drug, the third death was reported in the New England Journal of Medicine—a patient receiving Lecanemab was treated for acute ischemic stroke with tissue plasminogen activator and subsequently died from multiple cerebral hemorrhages.

The three deaths were all related to strokes, and the patients took blood thinner before or after Lecanemab treatment.

Though these cases are still under investigation, they suggest fatal brain hemorrhage could occur during treatment with Lecanemab.

For safety reasons, FDA approved that Leqembi should be initiated in patients with mild cognitive impairment or mild dementia and early Alzheimer's Disease, which is the same with the population in the clinical trials. The labeling on the drug also states no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

In the future, the FDA should address the balance of efficacy and safety of Lecanemab and keep an eye on adverse events. Longer trials are needed to explore the contraindications and side effects.

Updated from: https://www.theepochtimes.com/health/lecanemab-a-new-potential-drug-for-alzheimers-disease_4911902.html

Read more: Alzheimer's Disease series



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