2023-07-17 14:15:01
Delivery time2023-07-17 23:15
Eli Lilly “Slows cognitive decline by 35% in early phase 3 clinical trials”… Expect FDA approval
Expert “Concerns regarding effects and side effects only in early patients… Need to be careful with use”
(Seoul = Yonhap News) Correspondent Lee Joo-young = US pharmaceutical company Eli Lilly’s ‘Donanemab’, which is attracting attention as the third new drug for Alzheimer’s disease following ‘aducanumab’ and ‘lecanemab’, is undergoing clinical trials. In a phase 3 trial, it was reported to have the effect of slowing the progression of early Alzheimer’s disease.
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[제작 이태호] illustration
Eli Lilly’s Dr. John Sims’ team published in the medical journal ‘Journal of the American Medical Association’ (JAMA) on the 17th in a phase 3 clinical trial conducted for 76 weeks on 1,736 people with early symptoms of Alzheimer’s disease and brain amyloid/tau proteinopathy. It found that donanemab slowed cognitive decline by 35% compared to placebo in patients with low-to-moderate tau protein levels.
The research team said that this is similar to the effect of recanemab, which was approved by the US Food and Drug Administration (FDA) earlier this month. showed a 40% reduction in
However, Gil Rabinovich, a professor at the Center for Alzheimer’s Research at the University of California, San Francisco (UCSF), who was not involved in the clinical trial, said in an accompanying commentary, “The drug works well for people with early-stage Alzheimer’s disease, but not for people with advanced Alzheimer’s disease.” “It is recommended to be used cautiously considering the possibility of side effects.
Donanemab, which previously received breakthrough therapy designation from the FDA, is a monoclonal antibody drug that inhibits beta-amyloid plaque and tau protein in brain neurons, which are known to cause dementia. It has been expected that
In June 2021, the FDA approved aducanumab (Eduhelm) from Biogen of the United States and Eisai Pharmaceuticals of Japan as a new drug for Alzheimer’s disease, and in January of this year approved Recanemab (Rechembi) developed by the same two pharmaceutical companies. have done
All three drugs are new drugs that use the action of removing beta-amyloid plaques from the brain. Beta-amyloid plaques are known to interfere with brain nerve cell function and spread tau protein, and both beta-amyloid and tau proteins are presumed to be involved in the development of Alzheimer’s disease.
In clinical trials, it was shown that donanemab was more effective in removing amyloid plaques than adunatumab and recanemab and lowered the concentration of tau protein in the blood, but did not reduce the concentration of tau protein in important brain regions.
“The results of this clinical trial are encouraging, but further analysis is needed to understand the effect on patients,” said Professor Rabinovitch. Noticed.
“Patients with more advanced disease had little or no benefit compared to those who received a placebo,” he said. “With the potential for serious side effects, experts should aim to develop more effective and safer treatments for Alzheimer’s disease.” did.
In this clinical trial, amyloid-related adverse symptoms (ARIA) such as brain edema and microhemorrhage occurred in 3.7% of patients who received donanemab, including 3 deaths. It was found that those with
“Donanemab should be limited to patients with low to moderate tau protein levels and mild symptoms, and APOE4 genetic testing should be recommended prior to administration regarding side effects,” said Professor Rabinovitch.
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