The US Food and Drug Administration (FDA) has approved a new drug for patients in the early stages of Alzheimer’s disease. The treatment, called Leqembi (lecanemab), was heralded as a major breakthrough in the treatment of Alzheimer’s disease last year after early phase III data showing it could slow the progression of cognitive decline. But growing concerns about the drug’s safety and real-world efficacy have led to intense disagreements among researchers, and some believe the drug should be approved for widespread use. suggests that it is not.
Leqembi is the second approved in a new class of Alzheimer’s disease monoclonal antibody drugs designed to reduce brain accumulation of a protein called amyloid-beta, which is suspected to be the main pathological cause of Alzheimer’s disease. is a drug of The first approved drug in that class was his Aduhelm, which dates back to 2021. Questions about its efficacy, safety and ultimate price have led to the resignation of many FDA advisers, in what one expert called “probably the worst drug approval decision in recent US history.”
Despite Aduhelm’s FDA approval, the drug was not widely accepted by doctors and Alzheimer’s patients. Not only was the European Medicines Agency rejected for use in Europe, but a U.S. Congressional investigation into his approval of Aduhelm by the FDA found it violated a number of standard approval practices.
Eisai and Biogen, the same pharmaceutical companies behind the development of Aduhelm, are now conducting a second trial of Alzheimer’s disease monoclonal antibodies using Leqembi. Recently published Phase 3 clinical trial data showed that patients taking the drug for 18 months experienced a 27% slower rate of cognitive decline compared to patients in the placebo group.
Since the release of Phase 3 data in late 2022, many neurologists have questioned the real-world relevance of the cognitive benefits reported in Leqembi’s clinical studies. An open letter co-authored by 12 researchers recently opposed approval of Leqembi, suggesting the drug’s clinical benefits are uncertain.
“Analysis of the data available from CLARITY-AD suggests that the efficacy of lecanemab is lower than has been recognized as clinically meaningful,” the article states. , there are potential biases due to inclusion bias, unblinding, and dropout, among other issues that can affect data accuracy, with substantial adverse effects and subgroup heterogeneity evident. Therefore, the real-world impact of clinical trial data is highly uncertain.”
But perhaps even more serious are reports of patients participating in an extended Phase 3 clinical trial dying in recent months. The media recently reported three deaths of him from brain swelling and microhemorrhages.
An independent neuroscientist was asked by news outlet Science to review the patient’s records and concluded that the death was likely due to antibody treatment. But pharmaceutical company Eisai said the deaths were unrelated to Lekembi and all patient information was disclosed to the FDA before the drug was approved.
The FDA approval announcement for Leqembi noted a risk of brain swelling called “amyloid-associated imaging abnormalities (ARIA),” and the prescribing information required patients to take several drugs during the first four months of treatment to monitor for ARIA. I need to have a brain scan twice. .
In contrast to Leqembi’s critics, about 230 doctors and researchers co-signed a letter supporting clinical approval of the drug. Recambi is not a cure for Alzheimer’s disease, and while it won’t work for all patients, it is a fundamental advance in treating a disease that currently has no drug options, the letter said.
“Autonomy and justice provide for equitable access and opportunity for patients to make informed choices about reasonable treatment that may affect their lives and well-being. I am,” the letter said. “We cannot allow barriers to be placed between our patients and treatments that have a reasonable risk-benefit ratio and significantly reduce the underlying pathology.”
Rob Howard, Professor of Geriatric Psychiatry at University College London, is cautious about the safety and efficacy of Recambi. He thinks the drug’s side effect concerns are “understandable,” suggesting that doctors are cautious about prescribing the drug.
“Individual physicians will make their own decisions about prescribing lecanemab to their patients based on efficacy data from clinical trials and perceived risks associated with treatment,” Howard said. “In my own view, the benefits of the treatment seem too small to justify the risks, and I would not recommend it for my patients.”
Leqembi is given as an infusion every other week, and Eisai has priced the treatment at around US$26,500 annually.
Source: FDA
