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Written | Edited by Wang Cong | Typeset by Wang Duoyu | Shuichengwen On June 7, 2021, the FDA announced the accelerated approval of Bojian's monoclonal antibody drug aducanumab (trade name Aduhelm) for the treatment of mild Alzheimer's disease origin 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 aducanumabaducanumab was approved by the FDA, it immediately caused great controversy.
Clinical trials have shown that this monoclonal antibody can clear β-amyloid (Aβ) in the brain, but there is insufficient evidence that it can slow or prevent Alzheimer's disease.
The three FDA review experts resigned in protest because of the progress of the disease
.
The drug is expensive, up to 56,000 US dollars per year
.
Due to the lack of evidence of effectiveness and the risk of side effects, although the drug was approved by the US FDA for marketing, the major insurance companies in the United States refused to pay for the treatment of the drug
.
On November 22, 2021, JAMA Neurology journal published a paper titled: Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease
.
The paper reports on two large phase 3 clinical trials of aducanumab in the treatment of Alzheimer's disease, and focuses on the amyloid-related imaging abnormalities (ARIA) in patients during treatment
.
The test results showed that among 1029 patients in the 10mg/kg dose group, 425 patients (41.
3%) experienced amyloid-related imaging abnormalities (ARIA) problems, and 362 patients (35.
2%) developed ARIA cerebral edema, of which 94 People have symptoms such as headache, confusion, dizziness and nausea
.
197 patients (19.
1%) had ARIA microbleeds, and 151 patients (14.
7%) had ARIA surface iron deposits
.
Among these patients with side effects, 14 were in serious condition
.
These two large phase 3 clinical trials showed that more than 40% of patients had amyloid-related imaging abnormalities (ARIA) after receiving aducanumab treatment, and about a quarter of them had related symptoms
.
In November 2007, Biogen introduced the monoclonal antibody candidate aducanumab from Neurimmune for the treatment of early Alzheimer’s disease.
This monoclonal antibody drug can selectively interact with the brains of Alzheimer’s patients.
Beta-amyloid (Aβ) deposits and binds, and then activates the immune system to remove Aβ deposits in the brain
.
Since October 2017, Bojian and Eisai have cooperated on the development and commercialization of this monoclonal antibody globally
.
However, on March 21, 2019, Biogen announced the termination of the two global phase III clinical trials of aducanumab code-named ENGAGE and EMERGE.
The independent committee assessed that it is likely to be difficult to achieve the expected efficacy
.
As soon as this news came out, Bojian’s stock price plummeted 27%, and its market value shrank by US$15 billion.
.
Unexpectedly, on October 22, 2019, Biojian announced that after analyzing a larger data set, its medical data statistician found that aducanumab had a significant effect compared to placebo
.
So re-submitted the "Biologics License Application" (BLA) application to the FDA
.
Affected by this news, Bojian's share price soared by 40%
.
However, this is not over yet
.
On November 6, 2020, the FDA Peripheral and Central Nervous System Drug Advisory Committee re-applied for Bojian, and most members voted against it
.
In April 2021, Caleb Alexander, Scott Emerson, and Aaron Kesselheim, three members of the US FDA’s Peripheral and Central Nervous System Drug Advisory Committee, published an article in the JAMA journal criticizing aducanumab, saying that Bojian is shooting arrows first and then drawing targets
.
The aducanumab, which has come back from the dead, is still uncertain about its future.
The outside world is still full of doubts about whether the FDA will approve the Alzheimer’s drug candidate aducanumab developed by Bojian and Eisai, which also makes it the most watched drug development story in 2021 ( One)
.
In 18 years, the FDA approved the first new drug for Alzheimer's disease
.
On June 7th, local time in the United States, the FDA announced the accelerated approval of aducanumab developed by Biogen to treat patients with Alzheimer's disease .
Aducanumab has also become the first new treatment approved for Alzheimer's disease since 2003
.
Reference: https:// =featured_home https:// https://jamanetwork.
com/journals/jamaneurology/fullarticle/2786606 open reprint, welcome to forward to the circle of friends and WeChat group
.
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 aducanumabaducanumab was approved by the FDA, it immediately caused great controversy.
Clinical trials have shown that this monoclonal antibody can clear β-amyloid (Aβ) in the brain, but there is insufficient evidence that it can slow or prevent Alzheimer's disease.
The three FDA review experts resigned in protest because of the progress of the disease
.
The drug is expensive, up to 56,000 US dollars per year
.
Due to the lack of evidence of effectiveness and the risk of side effects, although the drug was approved by the US FDA for marketing, the major insurance companies in the United States refused to pay for the treatment of the drug
.
On November 22, 2021, JAMA Neurology journal published a paper titled: Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease
.
The paper reports on two large phase 3 clinical trials of aducanumab in the treatment of Alzheimer's disease, and focuses on the amyloid-related imaging abnormalities (ARIA) in patients during treatment
.
The test results showed that among 1029 patients in the 10mg/kg dose group, 425 patients (41.
3%) experienced amyloid-related imaging abnormalities (ARIA) problems, and 362 patients (35.
2%) developed ARIA cerebral edema, of which 94 People have symptoms such as headache, confusion, dizziness and nausea
.
197 patients (19.
1%) had ARIA microbleeds, and 151 patients (14.
7%) had ARIA surface iron deposits
.
Among these patients with side effects, 14 were in serious condition
.
These two large phase 3 clinical trials showed that more than 40% of patients had amyloid-related imaging abnormalities (ARIA) after receiving aducanumab treatment, and about a quarter of them had related symptoms
.
In November 2007, Biogen introduced the monoclonal antibody candidate aducanumab from Neurimmune for the treatment of early Alzheimer’s disease.
This monoclonal antibody drug can selectively interact with the brains of Alzheimer’s patients.
Beta-amyloid (Aβ) deposits and binds, and then activates the immune system to remove Aβ deposits in the brain
.
Since October 2017, Bojian and Eisai have cooperated on the development and commercialization of this monoclonal antibody globally
.
However, on March 21, 2019, Biogen announced the termination of the two global phase III clinical trials of aducanumab code-named ENGAGE and EMERGE.
The independent committee assessed that it is likely to be difficult to achieve the expected efficacy
.
As soon as this news came out, Bojian’s stock price plummeted 27%, and its market value shrank by US$15 billion.
.
Unexpectedly, on October 22, 2019, Biojian announced that after analyzing a larger data set, its medical data statistician found that aducanumab had a significant effect compared to placebo
.
So re-submitted the "Biologics License Application" (BLA) application to the FDA
.
Affected by this news, Bojian's share price soared by 40%
.
However, this is not over yet
.
On November 6, 2020, the FDA Peripheral and Central Nervous System Drug Advisory Committee re-applied for Bojian, and most members voted against it
.
In April 2021, Caleb Alexander, Scott Emerson, and Aaron Kesselheim, three members of the US FDA’s Peripheral and Central Nervous System Drug Advisory Committee, published an article in the JAMA journal criticizing aducanumab, saying that Bojian is shooting arrows first and then drawing targets
.
The aducanumab, which has come back from the dead, is still uncertain about its future.
The outside world is still full of doubts about whether the FDA will approve the Alzheimer’s drug candidate aducanumab developed by Bojian and Eisai, which also makes it the most watched drug development story in 2021 ( One)
.
In 18 years, the FDA approved the first new drug for Alzheimer's disease
.
On June 7th, local time in the United States, the FDA announced the accelerated approval of aducanumab developed by Biogen to treat patients with Alzheimer's disease .
Aducanumab has also become the first new treatment approved for Alzheimer's disease since 2003
.
Reference: https:// =featured_home https:// https://jamanetwork.
com/journals/jamaneurology/fullarticle/2786606 open reprint, welcome to forward to the circle of friends and WeChat group
