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On June 7, local time, the U.
S.
Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer's disease (AD) patients through accelerated approval
.
This is the first new treatment for Alzheimer's disease approved by the US FDA since 2003
.
S.
Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer's disease (AD) patients through accelerated approval
.
This is the first new treatment for Alzheimer's disease approved by the US FDA since 2003
.
More importantly, Aduhelm is the first therapeutic drug for the underlying pathophysiological mechanism of Alzheimer's disease, which is the presence of β-amyloid plaques in the brain
.
As a matter of fact, Alzheimer’s disease is the hardest hit area for drug research and development.
A number of research therapies have been "smashed" in later clinical trials.
Aduhelm, as the first Aβ-targeted therapy approved for marketing, will give this Drug innovation in a subdivision brings confidence
.
.
As a matter of fact, Alzheimer’s disease is the hardest hit area for drug research and development.
A number of research therapies have been "smashed" in later clinical trials.
Aduhelm, as the first Aβ-targeted therapy approved for marketing, will give this Drug innovation in a subdivision brings confidence
.
Regulatory Approval of Clinical Benefits
Accelerate approval to support listing
Alzheimer's disease (Alzheimer's disease) is a degenerative central nervous system disease that impairs the patient's thinking ability, memory and behavior independence, and can lead to premature death of the patient.
The patient progresses from an early stage to a severe disease.
It only takes 4 to 5 years
.
The patient progresses from an early stage to a severe disease.
It only takes 4 to 5 years
.
At present, Alzheimer's disease cannot be prevented or delayed, and it is rapidly becoming an increasingly serious global health crisis, bringing a huge burden to patients' families and society
.
As the sixth leading cause of death in the United States, Alzheimer's disease has more than 6 million patients in the United States, and this number is expected to increase as the population ages
.
.
As the sixth leading cause of death in the United States, Alzheimer's disease has more than 6 million patients in the United States, and this number is expected to increase as the population ages
.
Alzheimer's disease drug research has not been smooth sailing.
Since 2000, more than 200 clinical trials of Alzheimer's disease drug candidates have failed, with a failure rate of 99%
.
For a long time, Aduhelm's research and development process has attracted the attention of many groups such as the media, patients, and regulatory agencies
.
Since 2000, more than 200 clinical trials of Alzheimer's disease drug candidates have failed, with a failure rate of 99%
.
For a long time, Aduhelm's research and development process has attracted the attention of many groups such as the media, patients, and regulatory agencies
.
Aduhelm (aducanumab) is a research-use human monoclonal antibody for the treatment of Alzheimer's disease.
It is aimed at patients with mild cognitive impairment and mild Alzheimer's disease caused by Alzheimer's disease.
Research data shows that Aducanumab is expected to affect the pathophysiological mechanism of the disease, slow down cognitive and functional decline, and improve patients' ability of daily living, including personal financial management, housework activities (such as cleaning, shopping and laundry) and traveling alone
.
Once approved, Aducanumab will be the first treatment to significantly change the course of the disease in patients with Alzheimer's disease
.
It is aimed at patients with mild cognitive impairment and mild Alzheimer's disease caused by Alzheimer's disease.
Research data shows that Aducanumab is expected to affect the pathophysiological mechanism of the disease, slow down cognitive and functional decline, and improve patients' ability of daily living, including personal financial management, housework activities (such as cleaning, shopping and laundry) and traveling alone
.
Once approved, Aducanumab will be the first treatment to significantly change the course of the disease in patients with Alzheimer's disease
.
Under the accelerated approval mechanism, the US FDA will approve new therapies for serious or life-threatening diseases that are expected to bring significantly better therapeutic benefits than existing therapies, provided that the new drug is proven to have an impact on the alternative endpoint and the alternative The endpoint can reasonably predict the patient's clinical benefit
.
.
What has attracted much attention is that Aduhelm's later development plan includes two phase III clinical trials of EMERGE and ENGAGE, one of which reached the primary endpoint, showing that the patient's clinical decline has slowed, and the second trial did not meet the primary endpoint
.
Dr.
Patrizia Cavazzoni, director of the US FDA Drug Evaluation and Research Center, believes that in all the studies evaluated, Aduhelm convincingly reduced the level of amyloid plaques in the patients’ brains in a dose- and time-dependent manner.
The reduction of serotonin is expected to bring about a slowdown in the clinical decline of patients
.
.
Dr.
Patrizia Cavazzoni, director of the US FDA Drug Evaluation and Research Center, believes that in all the studies evaluated, Aduhelm convincingly reduced the level of amyloid plaques in the patients’ brains in a dose- and time-dependent manner.
The reduction of serotonin is expected to bring about a slowdown in the clinical decline of patients
.
Although at the meeting of the Peripheral and Central Nervous System Drug Advisory Committee in November 2020, the experts of the committee had different voices on the clinical benefits, but based on clinical trials, it is clear that the use of Aduhelm treatment can significantly reduce amyloid plaques In the end, the US FDA followed the institutional process of the accelerated approval mechanism and determined that Aduhelm met the regulatory requirements for accelerated approval
.
The review and approval concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweigh the risks of the therapy
.
.
The review and approval concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweigh the risks of the therapy
.
After the accelerated approval of Aduhelm for marketing, the US FDA will continue to monitor the listing of Aduhelm and ultimately monitor the patient's bedside conditions; in addition, the US FDA also requires Biogen to conduct a post-approval clinical trial to verify the clinical benefits of the drug If the drug fails to work as expected, the regulatory agency will be able to take measures to withdraw the drug from the market
.
.
"Terminal illness" turned into "chronic disease"
Clinical needs are met
After entering an aging society in 2000, China has quickly become one of the countries with the fastest population aging in the world
.
The latest census data show that China’s population of 60 years and over reaches 18.
70%.
As a common neurodegenerative disease in the elderly, Alzheimer’s disease has the characteristics of increasing prevalence and mortality with increasing age
.
.
The latest census data show that China’s population of 60 years and over reaches 18.
70%.
As a common neurodegenerative disease in the elderly, Alzheimer’s disease has the characteristics of increasing prevalence and mortality with increasing age
.
With the acceleration of aging, the number of patients with Alzheimer's disease in China is also increasing rapidly
.
Epidemiological data show that China is the country with the largest number of Alzheimer's disease patients in the world, accounting for one-fifth of the world
.
The number of patients with dementia caused by Alzheimer’s disease in China is as high as 9.
83 million; the number of patients with mild cognitive impairment is 38.
77 million; in addition, the annual economic expenditure of patients with Alzheimer’s disease in the country is approximately 166.
74 billion U.
S.
dollars, and its total value is approximately It accounts for 1.
47% of the national GDP
.
It is estimated that by 2030, the related expenditures caused by the disease will be as much as 500 billion US dollars
.
.
Epidemiological data show that China is the country with the largest number of Alzheimer's disease patients in the world, accounting for one-fifth of the world
.
The number of patients with dementia caused by Alzheimer’s disease in China is as high as 9.
83 million; the number of patients with mild cognitive impairment is 38.
77 million; in addition, the annual economic expenditure of patients with Alzheimer’s disease in the country is approximately 166.
74 billion U.
S.
dollars, and its total value is approximately It accounts for 1.
47% of the national GDP
.
It is estimated that by 2030, the related expenditures caused by the disease will be as much as 500 billion US dollars
.
Professor Chen Xiaochun, the president-elect of the Neurologist Branch of the Chinese Medical Doctor Association, the head of the Dementia and Cognitive Disorders Group of the Neurology Branch of the Chinese Medical Association, and the chief physician of the Neurology Department of Fujian Medical University Union Hospital, pointed out that Alzheimer’s disease is considered to be Caused by the accumulation of β-amyloid (Aβ) in the brain, Aducanumab is so far the first AD treatment drug with a clear therapeutic target, precise removal of Aβ, and a clear mechanism of drug action
.
“For example, the approval of statins and HIV treatment drugs has stimulated rapid development in the field of cardiovascular and AIDS treatment, and the approval of Aducanumab has also enabled mankind to take the initiative to transform Alzheimer’s disease from an incurable terminal illness to a controllable chronic disease.
A critical step in disease
.
"
.
“For example, the approval of statins and HIV treatment drugs has stimulated rapid development in the field of cardiovascular and AIDS treatment, and the approval of Aducanumab has also enabled mankind to take the initiative to transform Alzheimer’s disease from an incurable terminal illness to a controllable chronic disease.
A critical step in disease
.
"
At present, China's early screening, early diagnosis, early treatment, and full-course management of Alzheimer's disease are still far behind that of developed countries
.
The Communiqué of the Fifth Plenary Session of the 19th Central Committee of the Communist Party of China proposed for the first time the need to "implement a national strategy for actively responding to population aging" and to raise the response to population aging to the height of a "national strategy
.
Due to the high incidence of Alzheimer's disease and the lack of effective improvement and treatment methods, it has brought great challenges to human health in this era
.
.
The Communiqué of the Fifth Plenary Session of the 19th Central Committee of the Communist Party of China proposed for the first time the need to "implement a national strategy for actively responding to population aging" and to raise the response to population aging to the height of a "national strategy
.
Due to the high incidence of Alzheimer's disease and the lack of effective improvement and treatment methods, it has brought great challenges to human health in this era
.
Looking at the world, there are only a handful of successful research cases in the field of Alzheimer's disease, and the human struggle against Alzheimer's disease has been ongoing
.
Patients with Alzheimer's disease are a huge burden on the patients themselves and their families.
Aducanumab was approved by the US FDA, which brings new hope to patients with Alzheimer's disease and also brings new hope to Alzheimer's disease research.
The dawn
.
.
Patients with Alzheimer's disease are a huge burden on the patients themselves and their families.
Aducanumab was approved by the US FDA, which brings new hope to patients with Alzheimer's disease and also brings new hope to Alzheimer's disease research.
The dawn
.
Professor Wang Yongjun, Chairman of the Neurology Branch of the Chinese Medical Association, Director of the National Center for Medical Quality Control of Neurological Diseases, and Dean of Beijing Tiantan Hospital, said that the accelerated approval mechanism of the US FDA has paved the way for major innovations, especially in the fields of oncology and AIDS.
.
In 1993, the first multiple sclerosis therapy was also approved through an accelerated approval mechanism
.
"Today, we are very pleased to see that patients with Alzheimer's disease also benefit from this mechanism, and are delighted to see that companies all over the world are making unremitting efforts to delay the progress of Alzheimer's disease
.
Hopefully.
With the approval of new drugs, more patients and families can benefit
.
” ( Pharmaceutical Economic News )
.
In 1993, the first multiple sclerosis therapy was also approved through an accelerated approval mechanism
.
"Today, we are very pleased to see that patients with Alzheimer's disease also benefit from this mechanism, and are delighted to see that companies all over the world are making unremitting efforts to delay the progress of Alzheimer's disease
.
Hopefully.
With the approval of new drugs, more patients and families can benefit
.
” ( Pharmaceutical Economic News )
On June 7, local time, the U.
S.
Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer's disease (AD) patients through accelerated approval
.
This is the first new treatment for Alzheimer's disease approved by the US FDA since 2003
.
S.
Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer's disease (AD) patients through accelerated approval
.
This is the first new treatment for Alzheimer's disease approved by the US FDA since 2003
.
More importantly, Aduhelm is the first therapeutic drug for the underlying pathophysiological mechanism of Alzheimer's disease, which is the presence of β-amyloid plaques in the brain
.
As a matter of fact, Alzheimer’s disease is the hardest hit area for drug research and development.
A number of research therapies have been "smashed" in later clinical trials.
Aduhelm, as the first Aβ-targeted therapy approved for marketing, will give this Drug innovation in a subdivision brings confidence
.
.
As a matter of fact, Alzheimer’s disease is the hardest hit area for drug research and development.
A number of research therapies have been "smashed" in later clinical trials.
Aduhelm, as the first Aβ-targeted therapy approved for marketing, will give this Drug innovation in a subdivision brings confidence
.
Regulatory Approval of Clinical Benefits
Accelerate approval to support listing
Alzheimer's disease (Alzheimer's disease) is a degenerative central nervous system disease that impairs the patient's thinking ability, memory and behavior independence, and can lead to premature death of the patient.
The patient progresses from an early stage to a severe disease.
It only takes 4 to 5 years
.
The patient progresses from an early stage to a severe disease.
It only takes 4 to 5 years
.
At present, Alzheimer's disease cannot be prevented or delayed, and it is rapidly becoming an increasingly serious global health crisis, bringing a huge burden to patients' families and society
.
As the sixth leading cause of death in the United States, Alzheimer's disease has more than 6 million patients in the United States, and this number is expected to increase as the population ages
.
.
As the sixth leading cause of death in the United States, Alzheimer's disease has more than 6 million patients in the United States, and this number is expected to increase as the population ages
.
Alzheimer's disease drug research has not been smooth sailing.
Since 2000, more than 200 clinical trials of Alzheimer's disease drug candidates have failed, with a failure rate of 99%
.
For a long time, Aduhelm's research and development process has attracted the attention of many groups such as the media, patients, and regulatory agencies
.
Since 2000, more than 200 clinical trials of Alzheimer's disease drug candidates have failed, with a failure rate of 99%
.
For a long time, Aduhelm's research and development process has attracted the attention of many groups such as the media, patients, and regulatory agencies
.
Aduhelm (aducanumab) is a research-use human monoclonal antibody for the treatment of Alzheimer's disease.
It is aimed at patients with mild cognitive impairment and mild Alzheimer's disease caused by Alzheimer's disease.
Research data shows that Aducanumab is expected to affect the pathophysiological mechanism of the disease, slow down cognitive and functional decline, and improve patients' ability of daily living, including personal financial management, housework activities (such as cleaning, shopping and laundry) and traveling alone
.
Once approved, Aducanumab will be the first treatment to significantly change the course of the disease in patients with Alzheimer's disease
.
It is aimed at patients with mild cognitive impairment and mild Alzheimer's disease caused by Alzheimer's disease.
Research data shows that Aducanumab is expected to affect the pathophysiological mechanism of the disease, slow down cognitive and functional decline, and improve patients' ability of daily living, including personal financial management, housework activities (such as cleaning, shopping and laundry) and traveling alone
.
Once approved, Aducanumab will be the first treatment to significantly change the course of the disease in patients with Alzheimer's disease
.
Under the accelerated approval mechanism, the US FDA will approve new therapies for serious or life-threatening diseases that are expected to bring significantly better therapeutic benefits than existing therapies, provided that the new drug is proven to have an impact on the alternative endpoint and the alternative The endpoint can reasonably predict the patient's clinical benefit
.
.
What has attracted much attention is that Aduhelm's later development plan includes two phase III clinical trials of EMERGE and ENGAGE, one of which reached the primary endpoint, showing that the patient's clinical decline has slowed, and the second trial did not meet the primary endpoint
.
Dr.
Patrizia Cavazzoni, director of the US FDA Drug Evaluation and Research Center, believes that in all the studies evaluated, Aduhelm convincingly reduced the level of amyloid plaques in the patients’ brains in a dose- and time-dependent manner.
The reduction of serotonin is expected to bring about a slowdown in the clinical decline of patients
.
.
Dr.
Patrizia Cavazzoni, director of the US FDA Drug Evaluation and Research Center, believes that in all the studies evaluated, Aduhelm convincingly reduced the level of amyloid plaques in the patients’ brains in a dose- and time-dependent manner.
The reduction of serotonin is expected to bring about a slowdown in the clinical decline of patients
.
Although at the meeting of the Peripheral and Central Nervous System Drug Advisory Committee in November 2020, the experts of the committee had different voices on the clinical benefits, but based on clinical trials, it is clear that the use of Aduhelm treatment can significantly reduce amyloid plaques In the end, the US FDA followed the institutional process of the accelerated approval mechanism and determined that Aduhelm met the regulatory requirements for accelerated approval
.
The review and approval concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweigh the risks of the therapy
.
.
The review and approval concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweigh the risks of the therapy
.
After the accelerated approval of Aduhelm for marketing, the US FDA will continue to monitor the listing of Aduhelm and ultimately monitor the patient's bedside conditions; in addition, the US FDA also requires Biogen to conduct a post-approval clinical trial to verify the clinical benefits of the drug If the drug fails to work as expected, the regulatory agency will be able to take measures to withdraw the drug from the market
.
.
"Terminal illness" turned into "chronic disease"
Clinical needs are met
After entering an aging society in 2000, China has quickly become one of the countries with the fastest population aging in the world
.
The latest census data show that China’s population of 60 years and over reaches 18.
70%.
As a common neurodegenerative disease in the elderly, Alzheimer’s disease has the characteristics of increasing prevalence and mortality with increasing age
.
.
The latest census data show that China’s population of 60 years and over reaches 18.
70%.
As a common neurodegenerative disease in the elderly, Alzheimer’s disease has the characteristics of increasing prevalence and mortality with increasing age
.
With the acceleration of aging, the number of patients with Alzheimer's disease in China is also increasing rapidly
.
Epidemiological data show that China is the country with the largest number of Alzheimer's disease patients in the world, accounting for one-fifth of the world
.
The number of patients with dementia caused by Alzheimer’s disease in China is as high as 9.
83 million; the number of patients with mild cognitive impairment is 38.
77 million; in addition, the annual economic expenditure of patients with Alzheimer’s disease in the country is approximately 166.
74 billion U.
S.
dollars, and its total value is approximately It accounts for 1.
47% of the national GDP
.
It is estimated that by 2030, the related expenditures caused by the disease will be as much as 500 billion US dollars
.
.
Epidemiological data show that China is the country with the largest number of Alzheimer's disease patients in the world, accounting for one-fifth of the world
.
The number of patients with dementia caused by Alzheimer’s disease in China is as high as 9.
83 million; the number of patients with mild cognitive impairment is 38.
77 million; in addition, the annual economic expenditure of patients with Alzheimer’s disease in the country is approximately 166.
74 billion U.
S.
dollars, and its total value is approximately It accounts for 1.
47% of the national GDP
.
It is estimated that by 2030, the related expenditures caused by the disease will be as much as 500 billion US dollars
.
Professor Chen Xiaochun, the president-elect of the Neurologist Branch of the Chinese Medical Doctor Association, the head of the Dementia and Cognitive Disorders Group of the Neurology Branch of the Chinese Medical Association, and the chief physician of the Neurology Department of Fujian Medical University Union Hospital, pointed out that Alzheimer’s disease is considered to be Caused by the accumulation of β-amyloid (Aβ) in the brain, Aducanumab is so far the first AD treatment drug with a clear therapeutic target, precise removal of Aβ, and a clear mechanism of drug action
.
“For example, the approval of statins and HIV treatment drugs has stimulated rapid development in the field of cardiovascular and AIDS treatment, and the approval of Aducanumab has also enabled mankind to take the initiative to transform Alzheimer’s disease from an incurable terminal illness to a controllable chronic disease.
A critical step in disease
.
"
.
“For example, the approval of statins and HIV treatment drugs has stimulated rapid development in the field of cardiovascular and AIDS treatment, and the approval of Aducanumab has also enabled mankind to take the initiative to transform Alzheimer’s disease from an incurable terminal illness to a controllable chronic disease.
A critical step in disease
.
"
At present, China's early screening, early diagnosis, early treatment, and full-course management of Alzheimer's disease are still far behind that of developed countries
.
The Communiqué of the Fifth Plenary Session of the 19th Central Committee of the Communist Party of China proposed for the first time the need to "implement a national strategy for actively responding to population aging" and to raise the response to population aging to the height of a "national strategy
.
Due to the high incidence of Alzheimer's disease and the lack of effective improvement and treatment methods, it has brought great challenges to human health in this era
.
.
The Communiqué of the Fifth Plenary Session of the 19th Central Committee of the Communist Party of China proposed for the first time the need to "implement a national strategy for actively responding to population aging" and to raise the response to population aging to the height of a "national strategy
.
Due to the high incidence of Alzheimer's disease and the lack of effective improvement and treatment methods, it has brought great challenges to human health in this era
.
Looking at the world, there are only a handful of successful research cases in the field of Alzheimer's disease, and the human struggle against Alzheimer's disease has been ongoing
.
Patients with Alzheimer's disease are a huge burden on the patients themselves and their families.
Aducanumab was approved by the US FDA, which brings new hope to patients with Alzheimer's disease and also brings new hope to Alzheimer's disease research.
The dawn
.
.
Patients with Alzheimer's disease are a huge burden on the patients themselves and their families.
Aducanumab was approved by the US FDA, which brings new hope to patients with Alzheimer's disease and also brings new hope to Alzheimer's disease research.
The dawn
.
Professor Wang Yongjun, Chairman of the Neurology Branch of the Chinese Medical Association, Director of the National Center for Medical Quality Control of Neurological Diseases, and Dean of Beijing Tiantan Hospital, said that the accelerated approval mechanism of the US FDA has paved the way for major innovations, especially in the fields of oncology and AIDS.
.
In 1993, the first multiple sclerosis therapy was also approved through an accelerated approval mechanism
.
"Today, we are very pleased to see that patients with Alzheimer's disease also benefit from this mechanism, and are delighted to see that companies all over the world are making unremitting efforts to delay the progress of Alzheimer's disease
.
Hopefully.
With the approval of new drugs, more patients and families can benefit
.
” ( Pharmaceutical Economic News )
.
In 1993, the first multiple sclerosis therapy was also approved through an accelerated approval mechanism
.
"Today, we are very pleased to see that patients with Alzheimer's disease also benefit from this mechanism, and are delighted to see that companies all over the world are making unremitting efforts to delay the progress of Alzheimer's disease
.
Hopefully.
With the approval of new drugs, more patients and families can benefit
.
” ( Pharmaceutical Economic News )
