A treatment with monoclonal antibodies for the Alzheimer’s disease , called lecanemab, slows the progression of cognitive decline by 27% compared to a placebo, a substance without any effect on the body. The information was released by pharmaceuticals Biogen and Eisai on Tuesday (27).
The drug, tested in a global phase 3 clinical trial, also met all secondary endpoints, showing “targeted engagement” with reduced levels of amyloid – a protein that is one of the hallmarks of the disease – and positive effects on cognition and ability. to perform everyday tasks when compared to a placebo.
“We believe that helping to alleviate these burdens will positively impact society as a whole,” Eisai CEO Haruo Naito said in a statement. “Furthermore, the results of the lecanemab Clarity AD study support the amyloid hypothesis, in which abnormal accumulation of Aβ in the brain is a major cause of Alzheimer’s disease.”
However, researcher Richard Isaacson, director of the Alzheimer’s Prevention Clinic at the Brain Health Center at Florida Atlantic University’s Schmidt School of Medicine, told CNN that the study results are not proof of the amyloid hypothesis.
“This proves that in people with a certain amount of amyloid in the brain at a certain stage of the disease, this drug works. In terms of proving a mechanism for using a drug, no. Alzheimer’s is a very heterogeneous disease,” she said.
But he claims this does not diminish the potential significance of the essay. “In the past, the reduction of amyloid in the brain was not always linked to significant cognitive or clinical improvements. In this study, all outcomes were positive. This never happened before”.
Overall, there were side effects in 21.3% of study participants who took lecanemab, but Isaacson cautions that when people receive this type of treatment, they need to be closely monitored throughout the process. Symptomatic side effects are a more important measure, he says.
“When this medication is used correctly, the side effects are manageable and negative outcomes are preventable in most cases,” he said.
The rate of symptomatic ARIA-E, brain swelling, was 2.8% in study participants who took the drug and 0% in those who took the placebo. The rate of symptomatic ARIA-H, brain bleeding, and tissue iron accumulation was 0.7% in the drug group and 0.2% in the placebo group.
The Alzheimer’s Association expressed hope about the results.
“For people in the early stages of Alzheimer’s disease, this treatment has the potential to change the course of the disease in clinically significant ways,” the association said in a statement. “These results indicate that lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health decisions. Treatments that provide these benefits for people with mild cognitive impairment (MCI) due to Alzheimer’s disease and early-onset Alzheimer’s dementia are just as valuable as treatments that prolong the lives of people with other terminal illnesses.”
The view is shared by Isaacson: “I am imagining a world where, in the years to come, this type of treatment will be one of many tools in our toolbox in managing Alzheimer’s disease.”
While the findings come only from preliminary data, the companies say they plan to publish them in a peer-reviewed journal and plan to submit the data for approval from US regulatory authorities by the end of March.
Biogen is also the company behind another Alzheimer’s drug, Aduhelm, which was controversially approved by the US Food and Drug Administration (FDA), an agency similar to US Anvisa, in June 2021. Aduhelm was the first new Alzheimer’s drug approved in nearly 20 years, but there were doubts about its effectiveness and cost. The FDA quickly narrowed the pool of people who could receive it, and it’s unclear how many doctors will prescribe due to uncertainty surrounding its results.
Aduhelm was also the driving force behind a massive increase in Medicare Part B premiums for 2022 and restricted Medicare coverage in April.
Source: CNN Brasil
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