JAMA Neurology: New Alzheimer's disease drug marketed in controversy, more than one-third of patients have cerebral edema after treatment

On June 7, 2021, the FDA announced the accelerated approval of Bojian’s monoclonal antibody drug aducanumab (trade name Aduhelm) for the treatment of Alzheimer’s-induced mild cognitive impairment (MCI) and mild Alzheimer’s Disease
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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, it immediately caused great controversy.
Clinical trials have shown that this monoclonal antibody can clear beta-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 in protest against the progress of the disease
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The drug is expensive, up to 56,000 US dollars per year
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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

November 22, 2021, JAMA Neurologyjournal published a report entitled: Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Indicates Aducanumab of Alzheimer 'Disease in Patients With Early papers
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JAMA NeurologyJAMA Neurology Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease 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
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The results of the test showed that among the 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
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197 patients (19.

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
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Resurrected, ups and downs

Resurrection from the dead, great ups and downs

In November 2007, Biogen introduced aducanumab, a monoclonal antibody candidate for the treatment of early Alzheimer’s disease, from Neurimmune, which can selectively interact with the β-starch in the brains of Alzheimer’s patients.
Aβ-like protein (Aβ) deposits and binds, and then activates the immune system to clear the Aβ deposit protein in the brain
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Since October 2017, Bojian and Eisai have cooperated on the development and commercialization of this monoclonal antibody globally
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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
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As soon as the 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
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So re-submitted the "Biologics License Application" (BLA) application to the FDA

However, this is not over yet
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On November 6, 2020, the FDA Peripheral and Central Nervous System Drug Advisory Committee re-applied for Bojian, and most members voted against it
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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
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The future of aducanumab, which has come back from the dead, is still uncertain.
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)
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The first new drug for Alzheimer's disease approved by the FDA in 18 years

The first new drug for Alzheimer's disease approved by the FDA in 18 years The first new drug for Alzheimer's disease approved by the FDA in 18 years

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
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Aducanumab has also become the first new treatment approved for Alzheimer's disease since 2003

Original source:

Original source:

Stephen Salloway, et al.

Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease in this message