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On June 8, the U.
S.
Food and Drug Administration (FDA) approved Aducanumab, the first new drug to treat Alzheimer's disease in 18 years
.
Nature reported that this is very encouraging for patients who have been looking for a treatment for this "incurable" disease.
However, for many researchers, this is both a surprise and a disappointment
.
Aducanumab was developed by Biogen, a biotechnology company in Massachusetts, USA.
It is the first drug approved for the treatment of neurodegenerative diseases
.
It not only treats symptoms, but also attempts to treat the underlying causes of neurodegenerative diseases; but the approval of Aducanumab has sparked controversy over its effectiveness
.
Many experts, including an independent team of neurologists and biostatisticians, pointed out to the FDA that clinical trial data did not conclusively prove that Aducanumab can slow cognitive decline
.
Aducanumab is an intravenous monoclonal antibody drug, the latest product in a series of drug candidates aimed at solving amyloid plaques
.
Although no drugs of this type have been able to improve cognition so far, whether β-amyloid is the right drug target and whether researchers are testing the best treatment candidates, the right dosage, or the right patients, The problem still exists
.
The current drugs used to treat Alzheimer's disease only target the symptoms of the disease, such as delaying memory loss for several months
.
Aducanumab is designed to remove clumps of β-amyloid in the brain
.
Some researchers believe that this protein clump is the root cause of Alzheimer's disease
.
This theory is called the amyloid hypothesis
.
The FDA approved the drug based on its ability to reduce the level of protein plaques in the brain
.
Some researchers warn that the FDA is based on another method of measuring the effectiveness of drugs this time, which has set a dangerous precedent
.
Jason Karlawish, a geriatrician and co-director of the Philadelphia Memory Center in Pennsylvania, said: "Although the amyloid hypothesis has dominated this research field for decades, it links the reduction of plaque levels with the improvement of cognitive ability.
The evidence is still very weak
.
" He said: "The despair of drug development should promote funding for science, not the way we interpret science
.
" But some patient groups desperately need anything that might offset this incurable progressive disease.
The affected drugs
.
It is estimated that 35 million people worldwide currently suffer from this type of dementia
.
Maria Carrillo, chief scientific officer of the Alzheimer's Association, said in a statement: "History has told us that the approval of the first drug in the new category will stimulate the field to increase investment in new therapies.
And encourage greater innovation
.
We are full of hope for this, whether it is for this drug or to better treat Alzheimer’s disease, this is a good start
.
"Other scientists are worried about the approval of Aducanumab.
Will produce the opposite effect, and will hinder research work
.
Karlawish suspects that Alzheimer's patients may begin to withdraw from ongoing clinical trials to use Aducanumab
.
Other researchers worry that drug developers may abandon their goals
.
Some scientists say that if it proves that reducing the activity of amyloid is sufficient to win regulatory approval, it may prevent researchers from focusing on the huge cognitive improvements needed for patients
.
George Perry, a neurobiologist at the University of Texas at San Antonio and a skeptic of the amyloid hypothesis, said: "This will set the research community back 10 to 20 years
.
" The FDA's approval of Aducanumab is based on two phase III clinical trials.
Data
.
In March 2019, researchers looked at the interim data, and these trials in patients with early Alzheimer's disease concluded that it was unlikely to succeed, so Biogen terminated the two trials early
.
But a few months later, Biogen pulled the drug back from the edge after examining the data more closely
.
According to the company's re-analyzed data, in patients receiving the highest dose of Aducanumab monoclonal antibody, the rate of cognitive decline was statistically significantly slowed
.
Aducanumab did not show the same benefits when used at lower doses in this trial, and did not show benefits at any dose in another trial
.
For Paul Aisen, director of the Alzheimer's Treatment Institute at the University of Southern California: "All data support approval
.
My personal opinion is that Aducanumab is an effective therapy
.
But I admit that it is a there are problems of data collection
.
shows the situation worrisome
.
"The data also shows that Aducanumab monoclonal antibody also has non-negligible side effects
.
In the two phase III trials, about 40% of the treated patients developed brain swelling
.
Most of these patients did not develop any symptoms related to swelling, but they Regular brain scans are required to avoid dangerous complications
.
This is a burden for patients, neurologists and the medical system
.
At the meeting last November, 10 of the 11 panelists finally voted to provide the data can not be regarded as evidence of the effectiveness of Aducanumab; another abstained
.
This week, FDA has reached the opposite conclusion .
.
.
.
.
.
.
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.
.
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.
.
3.
NEJM: The effect of intermittent fasting on health, aging and disease 4.
Heal insomnia within one year! Research found: To improve sleep, you may only need a heavy blanket 5.
New Harvard research : Only 12 minutes of vigorous exercise can bring huge metabolic benefits to health.
6.
The first human intervention experiment: 28 days of "feeling and rolling" in nature is enough to improve immunity 7.
Junk food is "true" "Trash"! It takes away the length of telomeres and makes people grow old faster! 8.
Cell puzzle: you can die if you don’t sleep! But the lethal changes are not in the brain, but in the intestines.
.
.
9.
"Nature" Newsletter "Large-scale study: The level of iron in the blood is the key to health and aging! 10.
Unbelievable! Scientists reversed the "permanent" brain damage in animals overnight and restored the old brain to a youthful state.
.
.
S.
Food and Drug Administration (FDA) approved Aducanumab, the first new drug to treat Alzheimer's disease in 18 years
.
Nature reported that this is very encouraging for patients who have been looking for a treatment for this "incurable" disease.
However, for many researchers, this is both a surprise and a disappointment
.
Aducanumab was developed by Biogen, a biotechnology company in Massachusetts, USA.
It is the first drug approved for the treatment of neurodegenerative diseases
.
It not only treats symptoms, but also attempts to treat the underlying causes of neurodegenerative diseases; but the approval of Aducanumab has sparked controversy over its effectiveness
.
Many experts, including an independent team of neurologists and biostatisticians, pointed out to the FDA that clinical trial data did not conclusively prove that Aducanumab can slow cognitive decline
.
Aducanumab is an intravenous monoclonal antibody drug, the latest product in a series of drug candidates aimed at solving amyloid plaques
.
Although no drugs of this type have been able to improve cognition so far, whether β-amyloid is the right drug target and whether researchers are testing the best treatment candidates, the right dosage, or the right patients, The problem still exists
.
The current drugs used to treat Alzheimer's disease only target the symptoms of the disease, such as delaying memory loss for several months
.
Aducanumab is designed to remove clumps of β-amyloid in the brain
.
Some researchers believe that this protein clump is the root cause of Alzheimer's disease
.
This theory is called the amyloid hypothesis
.
The FDA approved the drug based on its ability to reduce the level of protein plaques in the brain
.
Some researchers warn that the FDA is based on another method of measuring the effectiveness of drugs this time, which has set a dangerous precedent
.
Jason Karlawish, a geriatrician and co-director of the Philadelphia Memory Center in Pennsylvania, said: "Although the amyloid hypothesis has dominated this research field for decades, it links the reduction of plaque levels with the improvement of cognitive ability.
The evidence is still very weak
.
" He said: "The despair of drug development should promote funding for science, not the way we interpret science
.
" But some patient groups desperately need anything that might offset this incurable progressive disease.
The affected drugs
.
It is estimated that 35 million people worldwide currently suffer from this type of dementia
.
Maria Carrillo, chief scientific officer of the Alzheimer's Association, said in a statement: "History has told us that the approval of the first drug in the new category will stimulate the field to increase investment in new therapies.
And encourage greater innovation
.
We are full of hope for this, whether it is for this drug or to better treat Alzheimer’s disease, this is a good start
.
"Other scientists are worried about the approval of Aducanumab.
Will produce the opposite effect, and will hinder research work
.
Karlawish suspects that Alzheimer's patients may begin to withdraw from ongoing clinical trials to use Aducanumab
.
Other researchers worry that drug developers may abandon their goals
.
Some scientists say that if it proves that reducing the activity of amyloid is sufficient to win regulatory approval, it may prevent researchers from focusing on the huge cognitive improvements needed for patients
.
George Perry, a neurobiologist at the University of Texas at San Antonio and a skeptic of the amyloid hypothesis, said: "This will set the research community back 10 to 20 years
.
" The FDA's approval of Aducanumab is based on two phase III clinical trials.
Data
.
In March 2019, researchers looked at the interim data, and these trials in patients with early Alzheimer's disease concluded that it was unlikely to succeed, so Biogen terminated the two trials early
.
But a few months later, Biogen pulled the drug back from the edge after examining the data more closely
.
According to the company's re-analyzed data, in patients receiving the highest dose of Aducanumab monoclonal antibody, the rate of cognitive decline was statistically significantly slowed
.
Aducanumab did not show the same benefits when used at lower doses in this trial, and did not show benefits at any dose in another trial
.
For Paul Aisen, director of the Alzheimer's Treatment Institute at the University of Southern California: "All data support approval
.
My personal opinion is that Aducanumab is an effective therapy
.
But I admit that it is a there are problems of data collection
.
shows the situation worrisome
.
"The data also shows that Aducanumab monoclonal antibody also has non-negligible side effects
.
In the two phase III trials, about 40% of the treated patients developed brain swelling
.
Most of these patients did not develop any symptoms related to swelling, but they Regular brain scans are required to avoid dangerous complications
.
This is a burden for patients, neurologists and the medical system
.
At the meeting last November, 10 of the 11 panelists finally voted to provide the data can not be regarded as evidence of the effectiveness of Aducanumab; another abstained
.
This week, FDA has reached the opposite conclusion .
.
.
.
.
.
.
read more: https: // -021-01546-2 2020 Hot Articles Featured 1.
The cup is full! A full paper cup of hot coffee, full of plastic particles.
.
.
2.
US, British and Australian scientists "Natural Medicine" add another strong proof: the new crown virus is a natural evolution Products, or have two origins.
.
.
3.
NEJM: The effect of intermittent fasting on health, aging and disease 4.
Heal insomnia within one year! Research found: To improve sleep, you may only need a heavy blanket 5.
New Harvard research : Only 12 minutes of vigorous exercise can bring huge metabolic benefits to health.
6.
The first human intervention experiment: 28 days of "feeling and rolling" in nature is enough to improve immunity 7.
Junk food is "true" "Trash"! It takes away the length of telomeres and makes people grow old faster! 8.
Cell puzzle: you can die if you don’t sleep! But the lethal changes are not in the brain, but in the intestines.
.
.
9.
"Nature" Newsletter "Large-scale study: The level of iron in the blood is the key to health and aging! 10.
Unbelievable! Scientists reversed the "permanent" brain damage in animals overnight and restored the old brain to a youthful state.
.
.
