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Recently, the US FDA has accelerated the approval of the monoclonal antibody therapy Aducanumab (Aduhelm) for the treatment of Alzheimer's disease (AD)
▌China has broken tens of millions of patients with dementia!
▌China has broken tens of millions of patients with dementia!
Alzheimer's disease (AD) is a progressive neurodegenerative disease.
▌Controversial innovative therapy: Aducanumab
▌Controversial innovative therapy: Aducanumab
Over the years, the research and development of drugs for Alzheimer's disease has never stopped, but only a few have succeeded, and even Aducanumab's road to market has been twists and turns
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In 2019, two global phase III clinical trials of Aducanumab, named ENGAGE and EMERGE, were terminated because they were unable to achieve the expected efficacy
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Moreover, in the two sets of experiments, one group found that β-amyloid plaque deposition was reduced, while the other group had no such effect, which caused great controversy in the scientific community
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Moreover, in the two sets of experiments, one group found that β-amyloid plaque deposition was reduced, while the other group had no such effect, which caused great controversy in the scientific community
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Subsequently, after larger data collection, it was found that the cognitive ability score of the high-dose Aducanumab group was significantly lower than that of the control group, and the deposition of amyloid plaques was also significantly reduced
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Therefore, in August last year, the FDA accepted Aducanumab's biologics license application and granted it priority review status
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Although it was delayed for three months, this approval decision also brought new hope to the development of amyloid-targeted therapies
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Although it was delayed for three months, this approval decision also brought new hope to the development of amyloid-targeted therapies
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Aduhelm is a fully human IgG1 monoclonal antibody that can selectively bind to the amyloid deposits in the brains of patients with Alzheimer's disease, stimulate an immune response, and then clear the deposited protein plaques
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▌The level of amyloid plaques is reduced, and innovative treatments are finally approved!
▌The level of amyloid plaques is reduced, and innovative treatments are finally approved!
This accelerated approval is based on three double-blind, randomized, placebo-controlled dose range studies, enrolling a total of 3,482 Alzheimer's disease patients
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The results show that:
◆ In patients treated with Aducanumab, the level of amyloid plaques in the brain was significantly reduced, while patients in the control group did not have a decrease in amyloid plaques
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◆ However, under the terms of accelerated approval, Aducanumab needs to conduct a new randomized controlled clinical trial to verify the clinical benefits of the drug
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Compared with the currently approved drugs, Aducanumab treats Alzheimer's disease in a new way and slows the progression of the disease
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At the same time, the approval of this new therapy also brings new hope for the treatment of targeted amyloid protein, which is expected to benefit more than 100 million Alzheimer's patients worldwide and reduce the burden
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At the same time, the approval of this new therapy also brings new hope for the treatment of targeted amyloid protein, which is expected to benefit more than 100 million Alzheimer's patients worldwide and reduce the burden
.
▌Where is the "outlet" for Alzheimer's treatment?
▌Where is the "outlet" for Alzheimer's treatment?
At present, there are more promising drugs under research, as well as the new targeted therapy for beta amyloid, Donanemab
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In a phase 2 clinical trial, Donanemab can not only delay the decline of patients' cognition and ability of daily living, but also quickly clear the amyloid deposits in the patient's brain
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I look forward to Donanemab's early completion of clinical research and bring good news to patients with dementia
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I look forward to Donanemab's early completion of clinical research and bring good news to patients with dementia
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In fact, drug research for Alzheimer's disease is not only aimed at amyloid, but also aimed at nerve synapses, neuroprotection, inflammation and other mechanisms of action
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In November 2019, the Chinese original drug targeting the brain-gut axis mannite sodium capsule (GV-971, ninth phase 1) was conditionally approved for marketing by the State Food and Drug Administration.
The indication is mild to moderate Alzheimer's disease
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The indication is mild to moderate Alzheimer's disease
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Like Aducanumab, GV-971 is always full of controversy from development to launch
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Last year, the drug launched an international multi-center phase III clinical trial in the United States
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Last year, the drug launched an international multi-center phase III clinical trial in the United States
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Although the Alzheimer's disease drugs under research have suffered a lot, only 3% may actually enter the phase III clinical trial, and the probability of successful listing in the end is very low
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From 1993 to now, there are only 5 new drugs approved by the FDA, namely tacrine (1993), donepezil (1996), rivastigmine (2000), galantamine (2001), and memantine (2003)
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And this new FDA approval has opened up a new era of Alzheimer's disease treatment and research, and will stimulate the investment and development of more innovative drugs, and it is possible to create more blockbuster new drugs in the future
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Reference materials:
Reference materials:
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