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Written | Edited by Wang Cong | Typeset by Wang Duoyu | Shui Chengwen On June 7, 2021, the FDA announced the accelerated approval of Bojian's monoclonal antibody drug aducanumab for the treatment of Alzheimer's disease-induced 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
.
Eli Lilly and other pharmaceutical companies have begun to submit applications to the FDA for Alzheimer's drugs targeting β-amyloid (Aβ) and hope to get approval
.
Alzheimer's disease (Alzheimer's disease, AD), commonly known as "Alzheimer's disease", is a severe neurodegenerative disease.
Patients usually suffer from symptoms such as memory decline, weakened learning ability, and emotional regulation.
Obstacles and loss of athletic ability greatly affect the development of individuals, families and society
.
Currently, about 50 million people worldwide suffer from Alzheimer's disease
.
As the average life expectancy of human beings has increased and the aging society has intensified, 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 complex, 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 been smashed.
In the entire field of new drug research and development, perhaps no one can be as ups and downs and exciting as the field of Alzheimer's
.
Biogen's aducanumab can selectively bind to the β-amyloid (Aβ) deposits in the brains of Alzheimer's patients, and then activate the immune system to clear the Aβ deposits in the brain
.
The FDA also approved its listing mainly based on this point
.
However, there is insufficient evidence that clearing Aβ from the brain can slow or stop the progression of Alzheimer's disease
.
Therefore, three FDA review experts resigned in protest after the drug was approved
.
In addition to Bojian's aducanumab, the Donanemab monoclonal antibody developed by Eli Lilly also targets β-amyloid (Aβ), and it has a better effect on clearing Aβ from the brain
.
On March 13, 2021, Eli Lilly and Company published a Phase 2 clinical trial paper entitled: Donanemab in Early Alzheimer's Disease in the New England Journal of Medicine (NEJM), the head of the four major international medical journals
.
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
.
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 results of the test showed that β-amyloid (Aβ) and Tau amyloid deposits in the patient’s brain were effectively removed, 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 that through the approval of aducanumab, a new era in the treatment of neurodegenerative diseases will be opened.
Some people believe that this approval will promote the development of brain disease data drugs.
Patients with Alzheimer's disease bring potentially fatal side effects
.
Reference: https:// =featured_homehttps:// is open for reprinting, welcome to forward to Moments and WeChat groups
.
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
.
Eli Lilly and other pharmaceutical companies have begun to submit applications to the FDA for Alzheimer's drugs targeting β-amyloid (Aβ) and hope to get approval
.
Alzheimer's disease (Alzheimer's disease, AD), commonly known as "Alzheimer's disease", is a severe neurodegenerative disease.
Patients usually suffer from symptoms such as memory decline, weakened learning ability, and emotional regulation.
Obstacles and loss of athletic ability greatly affect the development of individuals, families and society
.
Currently, about 50 million people worldwide suffer from Alzheimer's disease
.
As the average life expectancy of human beings has increased and the aging society has intensified, 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 complex, 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 been smashed.
In the entire field of new drug research and development, perhaps no one can be as ups and downs and exciting as the field of Alzheimer's
.
Biogen's aducanumab can selectively bind to the β-amyloid (Aβ) deposits in the brains of Alzheimer's patients, and then activate the immune system to clear the Aβ deposits in the brain
.
The FDA also approved its listing mainly based on this point
.
However, there is insufficient evidence that clearing Aβ from the brain can slow or stop the progression of Alzheimer's disease
.
Therefore, three FDA review experts resigned in protest after the drug was approved
.
In addition to Bojian's aducanumab, the Donanemab monoclonal antibody developed by Eli Lilly also targets β-amyloid (Aβ), and it has a better effect on clearing Aβ from the brain
.
On March 13, 2021, Eli Lilly and Company published a Phase 2 clinical trial paper entitled: Donanemab in Early Alzheimer's Disease in the New England Journal of Medicine (NEJM), the head of the four major international medical journals
.
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
.
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 results of the test showed that β-amyloid (Aβ) and Tau amyloid deposits in the patient’s brain were effectively removed, 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 that through the approval of aducanumab, a new era in the treatment of neurodegenerative diseases will be opened.
Some people believe that this approval will promote the development of brain disease data drugs.
Patients with Alzheimer's disease bring potentially fatal side effects
.
Reference: https:// =featured_homehttps:// is open for reprinting, welcome to forward to Moments and WeChat groups
