June 18, 2024

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First in 20 years New Alzheimer’s drug gets full FDA approval

First in 20 years New Alzheimer’s drug gets full FDA approval


First in 20 years New Alzheimer’s drug gets full FDA approval


On January 6, 2023, the Alzheimer’s disease drug lecanemab (trade name Leqembi) developed by Eisai and Biogen received conditional approval from the US FDA . Results from its phase 3 clinical trial showed the drug slowed the rate of cognitive decline by 27% in Alzheimer’s patients .

The FDA has since conducted a further review of the clinical trial results to determine whether the drug can be fully approved .


On June 10, 2023, at the US FDA Peripheral and Central Nervous System Drugs Advisory Committee meeting, committee experts voted unanimously 6:0 to fully approve lecanemab (trade name Leqembi) . The FDA is expected to make a final decision by July 6 of this year.


On July 6, 2023,  FDA announced that the new drug lecanemab (trade name Leqembi) for Alzheimer’s disease will be converted to traditional approval.

It is reported that this is the first Alzheimer’s disease drug that targets β-amyloid protein and has been converted from accelerated approval to traditional approval, and it is also the first new Alzheimer’s disease drug that has been fully approved by the FDA in 20 years.


The FDA decision will have special significance because the Medicare agency has been delaying approval for lecanemab .

Reimbursement paid until it can be fully approved by the FDA, its treatment costs $26,500 per year.


Lecanemab is also jointly developed by Eisai and Biogen . On November 29, 2022, the Phase III clinical trial results of the drug were published in the New England Journal of Medicine (NEJM ) .

Results from a clinical trial in early-stage Alzheimer’s patients showed the drug slowed cognitive decline by 27 percent in Alzheimer’s patients .


First in 20 years New Alzheimer's drug gets full FDA approval


Lecanemab is a humanized IgG1 monoclonal antibody that works by binding to β-amyloid (Aβ) .


These early-stage Alzheimer’s patients received intravenous lecanemab or a placebo every two weeks for 18 months, and the researchers measured their cognitive abilities on an 18-point scale. The results showed that lecanemab delayed the time to disease progression in patients by about 5 months .

Additionally, patients who received lecanemab were 31 percent less likely to progress to the next stage of their disease during the study period.


First in 20 years New Alzheimer's drug gets full FDA approval


In addition, the adverse reactions in the clinical trial results have caused controversy. 17.3% of patients receiving the drug experienced cerebral hemorrhage (compared with 9% in the placebo control group) , and 12.6% of patients experienced brain swelling (compared with 1.7% in the placebo control group). ) .


In fact, Alzheimer’s disease experts are still divided on how much these changes that the drug brings to Alzheimer’s patients will affect patients and their families.


For example, Dr. Ron Petersen , an Alzheimer’s disease specialist at the Mayo Clinic , believes the drug’s effect is modest, but it’s clinically meaningful. Because even delaying disease progression for a few months can give Alzheimer’s patients a little more time to live/work independently for longer.


Maria Carrillo , chief scientist at the Alzheimer’s Association , said the clinical trial is important because it shows that targeting amyloid with drugs can delay Alzheimer’s disease progression.

Delaying cognitive decline in the early stages of Alzheimer’s disease has important implications, allowing patients to spend more time with loved ones, enjoy family life, travel, vacation, and bucket list.


Drugs that target Aβ can cause side effects including brain swelling and bleeding in the brain, and lecanemab is no exception, and Eisai said most patients had mild or no symptoms.


According to public reports, three Alzheimer’s patients died during clinical studies of the drug, two of whom died from strokes caused by cerebral hemorrhages, which Eisai said were taking blood thinners for other health problems. The deaths could not be attributed to Alzheimer’s drugs.


The chairman of the FDA Peripheral and Central Nervous System Drugs Advisory Committee and Professor Robert Alexander of the University of Arizona  said that from the results of clinical trials, lecanemab has side effects, but which side effects can be monitored, and the benefits it brings to patients It is obvious.






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First in 20 years New Alzheimer’s drug gets full FDA approval

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