Another new drug for Alzheimer's disease is here! Monthly injection therapy, with the best results for the "earliest" patients
2024-07-05
The global aging population is rolling in, and the treatment of age-related cognitive impairment diseases is receiving much attention. Recently, another new drug for Alzheimer's disease has arrived. On July 2nd, the US Food and Drug Administration (FDA) approved Eli Lilly's Kisunla Alzheimer's disease therapy for the treatment of early symptomatic Alzheimer's disease (AD) in adults, including patients with mild cognitive impairment (MCI) and those with mild dementia stage AD and confirmed amyloid pathological changes. This is the first and only evidence to support the cessation of medication after clearing amyloid plaques, with the potential to reduce treatment costs and reduce infusion frequency. Its usage is intravenous infusion once a month. Alzheimer's disease can lead to intellectual disabilities, mental abnormalities, and loss of social and life functions in patients, seriously affecting their cognitive abilities and normal life. The development of its new drugs has a high failure rate of over 99%, and patients have long been in the dilemma of lacking medical treatment and medication. Amyloid protein is a naturally occurring protein in the body that can aggregate to form amyloid plaques. The excessive accumulation of amyloid plaques in the brain may lead to memory and thinking problems associated with Alzheimer's disease. Kisunla can help the body clear excessive accumulation of amyloid plaques and alleviate situations that may lead to people's inability to remember new information, important dates and meetings, plan management, cooking, using household appliances, managing finances, and declining independent self-care abilities. In the third phase of the new drug study, it was shown that patients with the earliest disease progression were most effective in using Kisunla. During the 18 month trial period, participants were divided into two groups for analysis: the group with early disease progression (with low to moderate levels of tau protein) and the overall population, including subjects with low, medium, and high tau levels. The use of Kisunla treatment can significantly slow down clinical decline in both groups of people. In the population with early disease progression, patients receiving Kisunla treatment showed a significant 35% reduction in the rate of decline in memory, thinking, and daily functions on the Integrated Alzheimer's Disease Rating Scale (iADRS) compared to placebo. According to the iADRS scale, drug therapy significantly slowed down the overall population by 22%. Among the two groups of participants, those receiving Kisunla treatment showed a 39% reduction in the risk of disease progression to the next clinical stage compared to those receiving placebo. In the overall subject population, compared to the start of the study, Kisunla showed an average reduction of 61% in amyloid plaques after 6 months of use, 80% at 12 months, and 84% at 18 months. One therapeutic goal of the study is to reduce amyloid plaques to levels consistent with visually negative amyloid positron emission tomography (PET). If it is confirmed that the subject has reached this level, Kisunla treatment will be completed and switched to placebo during the remaining time of the study. It is worth noting that Lilly Pharmaceuticals also reminds that Kisunla may lead to imaging abnormalities ("ARIA") associated with targeted therapy for amyloid plaques. It can be detected by magnetic resonance imaging scanning, which may manifest as temporary swelling in brain regions that usually disappears over time; Occasionally, bleeding may occur in larger areas of the brain. ARIA may cause life-threatening effects. Kisunla may also cause certain allergic reactions, some of which may be severe and life-threatening. Headache is another common side effect. This approval marks another step in advancing the standard treatment process for Alzheimer's disease patients, ultimately including a series of new treatment methods, providing much-needed hope for the Alzheimer's disease population. As a doctor, I am encouraged to adopt a limited course of treatment, which may reduce patients' self funded costs and infusion burden Howard Fillit, co-founder and Chief Scientific Officer of the Alzheimer's Drug Discovery Foundation, said that buying valuable time for patients is expected to allow them to remain independent for a longer period of time. It is reported that Kisunla is priced at $695.65 per bottle, and based on previous trial results, the cost of 12 months of treatment is $32000. If the plaques in the brain decrease to the lowest level, doctors can choose to discontinue medication. Previous studies have shown that some patients have stopped taking medication after one year of treatment. According to public information, in October last year, the Drug Evaluation Center of China's National Medical Products Administration showed that Eli Lilly submitted its application for the new drug to the market and was accepted; In January of this year, it was proposed to be included in the breakthrough therapy by CDE, with a proposed indication for early symptomatic Alzheimer's disease. (Lai Xin She)
Edit：Xiong Dafei Responsible editor：Li Xiang
Source：WHB
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