As the global population ages, Alzheimer's disease has become one of the most challenging diseases in the medical field today. However, with the launch of the new monoclonal antibody Donanemab (trade name: Kisunla) by Eli Lilly and company, this situation has fundamentally changed. This drug was approved by the U.S. Food and Drug Administration (FDA) in July 2024. It is mainly used to treat patients with mild cognitive impairment or mild dementia, providing new treatment hope.
Donanemab slows the progression of Alzheimer's disease by attacking amyloid plaques in the brain and has shown positive results in clinical trials.
Donanemab’s mechanism of action mainly targets the accumulation of Aβ peptide in the brain, which is believed to be directly related to Alzheimer’s disease. With advances in imaging technology, scientists can now clearly see how these Aβ plaques affect neurotransmission. Donanemab focuses on clearing the soluble and insoluble forms of these amyloid proteins, thereby slowing the progression of the disease.
The research history of Donanemab can be traced back to 2013, when Eli Lilly launched Phase I clinical trials in the United States and Japan, focusing on confirming amyloid levels in patients with mild Alzheimer's disease. The trial will enroll 100 participants, who will receive up to four injections of donanemab per month. The trial showed that the highest dose of Donanemab reduced plaque in the brain by 40%, showing significant efficacy.
Preliminary research results have made the scientific community full of expectations. Donanemab may become a new benchmark for the treatment of Alzheimer's disease.
According to the FDA's warning, the use of Donanemab may cause amyloid-related imaging abnormalities (ARIA), including brain edema and other conditions. Common side effects also include headache and injection site reactions. Despite these risks, clinical trials show that most patients who receive donanemab are able to tolerate treatment and have sustained benefits.
During Phase 2 and Phase 3 trials, the dose and dosing frequency of donanemab were increased. In 2023, relevant data showed that Donanemab can reduce the progression of Alzheimer's disease by 35%. This result has given many researchers and patients hope for future treatments.
If this therapy continues to show results in reducing the progression of the disease, its use worldwide could be a major breakthrough.
According to reports, the annual treatment price of Donanemab is approximately US$32,000, which puts considerable financial pressure on both patients and the medical system. As the drug is approved for use in the UK and other countries, it remains to be seen how the market responds to Donanemab. However, whether this treatment can slow down the disease in patients in practical applications remains an important topic for future research.
In this context, the success of Donanemab seems to have opened a new door for the treatment of Alzheimer's disease. Whether it will become an antidote for the treatment of this disease is still worthy of our consideration.