Image source,Getty Images
Alzheimer’s disease is plagued by 30 million people worldwide.
The U.S. Food and Drug Administration (FDA) approved the use of the new drug aducanumab for Alzheimer’s disease (Alzheimer’s disease; also translated as Alzheimer’s disease) for the first time since 2003.
Adukanumumab, developed by Biogen, a pharmaceutical company in Cambridge, Massachusetts, claims to be able to directly deal with the root cause of Alzheimer’s disease and achieve “cure the root cause.” The US FDA approval will provide conditions for the use of this drug in other countries.
Relevant charitable organizations in the United Kingdom and the United States have welcomed the news that the new drug has been approved. However, the medical and scientific communities still have different views on Adukanumumab, and some researchers have doubts about the clinical research data of this drug.
The U.S. FDA emphasized that the reviewers have “substantial evidence that adukanumumab can reduce amyloid beta plaques (Aβ plaques) in the brain”. The bureau believes that this is expected to bring “great benefits to patients”. benefit”.
Different names for dementia in the Chinese world
- Dementia (World Health Organization)
- Alzheimer’s (Mainland China)
- Dementia (Hong Kong)
- Dementia (Macau, Taiwan, Singapore)
Source: World Health Organization, National Health Commission of China, Hong Kong Hospital Authority, Macau Health Bureau, Singapore Dementia Association
In the United States, Alzheimer’s disease is the sixth leading cause of death. The Alzheimer’s Association predicts that by 2050, the number of patients nationwide will increase from the current 6 million to 13 million; the UK currently has about 500,000 patients.
According to articles from the Alzheimer’s Disease Branch of the Chinese Geriatric Healthcare Association and the official Xinhua News Agency, there are currently 10 million Alzheimer’s patients in China, and it is estimated that by 2050, it will exceed 40 million.
Encouraged by the FDA’s decision, the price of Biogen’s trading shares in the United States soared by 50% on Monday (June 7), and finally closed at $395.85 per share, an increase of 38.3%. Biogen’s research and development partner-Japan’s Eisai Corporation-shares in the US trading rose 56% on Monday to close at $116.03 per share.
Adukanumumab clinical trial
Adukanumumab prevents the destruction of brain tissue by dealing with amyloid.
Alzheimer’s disease continues to damage brain tissue, causing patients to lose memory and become disoriented, which may cause patients to be unable to take care of their daily lives. The patient’s mood may also fluctuate greatly, or even have communication difficulties.
Biogen claims that its adukanumumab can deal with amyloid, a protein that forms abnormal clumps in the brain. Because of the appearance of amyloid, brain cells will be destroyed, causing dementia symptoms, such as:
- Memory and thinking disorders
- Communication barriers
- Feel confused
In March 2019, the late global clinical trial of Adukanumumab was suddenly stopped. The trial involved 3,000 patients, who were administered medications by intravenous injection once a month. However, data analysis shows that the new drug is no better than a placebo in slowing down memory decline and thinking disorders.
But later in the same year, Biogen claimed that after analyzing more clinical data, it believed that as long as the dose was increased, Adukanumumab could effectively treat Alzheimer’s disease, including significantly delaying cognitive decline.
Biogen will sell Adukanumumab under the name Aduhelm, with an estimated annual cost of $56,000 per person.
Aldo Ceresa is one of 3,000 Alzheimer’s patients who participated in the clinical trial of Adukanumumab.
68-year-old British patient Aldo Ceresa (Aldo Ceresa) was originally a surgeon. Ten years ago, he was diagnosed with Alzheimer’s disease and was forced to resign because he found that he could not tell the difference between the left and right.
He participated in Biogen’s new drug trial until the trial was stopped. He has been using Adukanumumab for two years. Now he has to wait for the National Hospital for Neurology and Neurosurgery in London to start a clinical trial of another drug before he can get treatment.
Ceresa believes that Adukanumumab will provide substantial help to his condition, and his family will also see significant improvement.
Ceresa told a BBC reporter: “I thought of picking up something from the kitchen, but I couldn’t remember where it was placed. Now the problem is not that big.”
“I’m not going to return to my original state, but I’m finally moving in the right direction.”
Analysis: “Celebrate cautiously”
BBCMedical Editor Fergus·Walsh (Fergus Walsh）
This is not a miraculous drug, nor can it cure Alzheimer’s disease, but it is the first treatment to deal with the destruction mechanism in the brain that causes the destruction of neurons.
This is why this moment has iconic significance.
But the scientific community in both the United Kingdom and the United States is divided. Some people welcome the approval of the new drug and call it a milestone moment for millions of Alzheimer’s patients. Others believe that the drug can only bring marginal benefits ( marginal benefits).
British charities concerned about Alzheimer’s disease say they will put pressure on the government to decide as soon as possible whether to approve the new drug, but that may have to wait another year.
Finally, we don’t know much about the cost of adukanumumab—perhaps tens of thousands of pounds per person per year. Even if it is approved, only patients who have been diagnosed with a special brain scan can benefit.
There are many footnotes, and at this moment we can only celebrate very carefully.
Controversy in the medical world
Patients participating in the clinical test of Adukanumumab receive regular brain scans to evaluate the efficacy of the drug.
Professor Bart De Strooper, director of the UK Dementia Research Institute, said that adukanumumab is approved for use and is “extremely important for seeking treatment for Alzheimer’s disease.” Milestone”, but he also admitted that “there are still many hurdles to be crossed.”
In the past 10 years, more than 100 potential treatments for Alzheimer’s disease have ended in research failures.
Professor John Hardy, professor of neuroscience at University College London, said: “We have to understand clearly that in the best case, this drug can only bring marginal benefits to carefully selected patients. .”
Dr Howard Fillit, Chief Scientific Officer of the Alzheimer’s Drug Discovery Foundation (ADDF) said: “I think they (the US FDA) made the right decision. This allows Patients can obtain new drugs, and at the same time require pharmaceutical companies to continue research to prove their efficacy.”
Professor Caleb Alexander, co-director of the Center for Drug Safety and Pharmacodynamics at Johns Hopkins University School of Medicine (Johns Hopkins Medicine), is an advisory committee member of the US FDA. He voted against the use of Adukanumumab .
Professor Alexander said: “I am surprised and disappointed. It is very difficult for you to find a scientist who believes that the evidence is sufficient, even if it is a scientist connected with a pharmaceutical factory.”
Professor Robert Howard of Aging Psychiatry at University College London even described the US decision to approve Adukanumumab as a “serious error”. He criticized the FDA for ignoring clinical research data showing that the new drug failed to slow down the recognition. The fact that knowledge is degraded may destroy meaningful research on the treatment of dementia in the past 10 years.
Cheers from patients and support groups
Image source,Science Photo Library
The accumulation of amyloid plaques in the brain leads to the destruction of neurons, causing Alzheimer’s disease.
Alzheimer’s disease groups are encouraged by the decision of the US authorities.
The American Alzheimer’s Association said on Twitter: “On behalf of patients affected by Alzheimer’s disease and various dementias, we celebrate today’s historic decision.”
Alzheimer’s Society UK believes that new drugs offer hope to patients, but this is only the first step in the development of Alzheimer’s treatment.
Alzheimer’s Research UK (Alzheimer’s Research UK) stated that it has sent a letter to the British Minister of Health Matt Hancock (Xia Guoxian), requesting that the United Kingdom speed up the progress of the approval of Adukanumab. President Hilary Evans said: “Dementia patients and their families have been waiting for this new life-changing therapy for too long.”
Traditionally, financial support for research on dementia treatments is much lower than for cancer or heart disease. Although the medical community has severely divided opinions on Adukanumumab, the US authorities approved this drug this time, which is expected to greatly boost research on the treatment of dementia.