June 25, 2024

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More and more monoclonal antibodies for Alzheimer disease enter FDA reviewing


More and more monoclonal antibodies for Alzheimer disease enter FDA reviewing.


June 7, 2021, the FDA announced the accelerated approval Bo Jian of monoclonal antibody drugs aducanumab on the market for the treatment of Alzheimer’s disease -derived mild cognitive impairment (MCI) and mild Alzheimer’s disease .

This is the first new drug approved by the FDA for the treatment of Alzheimer’s disease since 2003, and it is also the first drug that can prevent the progression of the disease.


After aducanumab was approved by the FDA, although it caused great controversy, it still ignited the passion in the field of Alzheimer’s drug research and development, and gave a boost to the failing new drug research and development field of Alzheimer’s .


Lilly and other pharmaceutical companies have started targeting submitted to the FDA beta-amyloid (Aβ) of Alzheimer’s disease application of drugs, and hope to be approved.


More and more monoclonal antibodies for Alzheimer disease enter FDA reviewing


Alzheimer’s disease (Alzheimer’s disease, AD) , commonly known as ” Alzheimer’s disease “, is a serious neurodegenerative disease. Patients usually suffer from memory decline and weakened learning ability, accompanied by emotional regulation. Obstacles and loss of athletic ability greatly affect the development of individuals, families and even society.


Currently, there are around 50 million people suffer from Alzheimer’s disease . As the average life expectancy of human beings increases and the aging society intensifies, the prevalence of Alzheimer ‘s disease is also rising. It is estimated that by 2050, the number of patients with Alzheimer’s disease will increase to more than 150 million .


Regrettably , the cause of Alzheimer’s disease is complicated, and the scientific community has not yet deciphered the specific mechanism of the disease. The mainstream view is that the cause is the deposition of β-amyloid (Aβ) and Tau amyloid, which causes a large number of neuronal deaths. .


However, in recent years , clinical trials of Alzheimer’s drugs targeting these two targets have failed. In the entire field of new drug research and development, perhaps no one can be as ups and downs as the field of Alzheimer’s .


Bo health of aducanumab is capable of selectively Alzheimer brain patients β- amyloid (A [beta]) binding is deposited, and then by activating the immune system to clear the deposited A [beta] protein in the brain.

The FDA also approved its listing mainly based on this. However, there is insufficient evidence that clearing Aβ from the brain can slow or prevent the progression of Alzheimer’s disease .

Therefore, three FDA review experts resigned in protest after the drug was approved.


In addition Bo health of aducanumab outer, Lilly Development Donanemab single anti also targeted to β- amyloid (A [beta]) , and its clearing A [beta] in terms of better brain.


March 13, 2021, Eli Lilly and Company in the first of the big four international medical journal ” New England Journal of Medicine ” (NEJM) published a report entitled: Donanemab of Alzheimer ”s Disease Early in 2 clinical trial papers. Donanemab monoclonal antibody reached the primary endpoint in the phase 2 clinical trial, and the deposits of β-amyloid (Aβ) and Tau amyloid in the patient’s brain were effectively eliminated.


More and more monoclonal antibodies for Alzheimer disease enter FDA reviewing


Donanemab monoclonal antibody can target and bind β-amyloid (Aβ) modified by pyroglutamate at position 2 of the N-terminal to quickly and completely remove amyloid deposits.


In this phase 2 clinical trial involving 257 patients with Alzheimer’s disease , 131 received Donanemab monoclonal antibody treatment developed by Eli Lilly and the remaining 126 received placebo treatment for 72 weeks.


The test results showed that the β-amyloid (Aβ) and Tau amyloid deposits in the patient’s brain were effectively eliminated, and Donanemab monoclonal antibody reached its primary endpoint . In terms of cognition and daily function, these symptomatic early Alz The rate of decline in the Integrated Measurement of Cognition and Daily Functioning (iADRS) in patients with Alzheimer’s disease slowed by 32%.


Overall, in patients with early Alzheimer’s disease , Donanemab monoclonal antibody treatment can significantly slow the decline of patients’ cognitive and daily function, although the secondary endpoint has mixed results.


Eli Lilly also conducted a head-to-head experiment on donanemab and aducanumab to directly compare their ability to reduce Aβ. The results show that donanemab is superior to aducanumab in eliminating Aβ .


Therefore, Eli Lilly submitted a marketing application for donanemab to the FDA . Since the FDA approved aducanumab , why not approve donanemab ?


In addition to Bojian and Eli Lilly , Alzheimer’s drug research and development companies that target β-amyloid (Aβ) include Acumen , Alzheon , Alzinova , Cognition , Eisai , Novartis , Prothena , Roche and other companies.


The FDA hopes to aducanumab approved, the new open when the treatment of neurodegenerative diseases on behalf of, some people think that this approval will facilitate the development of brain disease drug information, some people thought it would be FDA stain, as well as people think it will to Alzheimer’s disease patients with potentially fatal side effects.





More and more monoclonal antibodies for Alzheimer disease enter FDA reviewing

(source:internet, reference only)

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