New drug for Alzheimer's disease developed jointly by Japan and the United States
04.07.2021
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The emergence of a new drug for the treatment of Alzheimer's disease brings hope to the many elderly people with dementia in a rapidly aging Japan.
Although the drug has not yet received approval in the country, US regulators have given it a green light. Aducanumab, the result of a joint development by the American firm Biogen and the Japanese pharmaceutical company Eisai, is the first new Alzheimer's drug in almost two decades. Unlike other drugs, it aims to eliminate the cause of the disease, not to alleviate the symptoms.
The drug's market name is Aduhelm. It destroys protein plaques that form between brain neurons and lead to cognitive impairment. The US Food and Drug Administration (FDA) approved the new drug in early June, after results from clinical trials showed it could slow the progression of Alzheimer's disease when taken early enough.
The Japanese Ministry of Health has been considering an application for approval of the drug since December last year. Some experts are unsure of the drug's effectiveness, and worry about the cost and how quickly it got approved in the US. Alzheimer's sufferers, their families and caregivers are cheering the new drug.
“We are full of hope because the drug has been approved in the US for the treatment of pathology. I really hope it gets approved in Japan soon,” says Mori Yoshihiro, who leads a support group for early-onset Alzheimer's patients and their families.
“Patients have been disappointed many times Mori.
About six million people in Japan have dementia, and it is estimated that about 60% of them have Alzheimer's disease. This figure is likely to rise as Japanese society ages. Iwasa Marie cares for her mother, who developed early onset of Alzheimer's disease. She says that dementia is a cruel test for both the patients themselves and their families. Her mother, now 72, was diagnosed at 58. Since then, her condition has been deteriorating inexorably, and now she can barely even remember her daughter's name.
“I often feel despair, realizing that this disease is incurable. It’s unspeakably hard just to watch my mother fade away,” says Iwasa. “I don’t wish any family to experience what we had to endure.” Iwasa Marie showed a photo of her mother’s blank expression and wrote about the shock she experienced when she realized that she barely recognizes her.
Biogen is already distributing the drug in the United States, and it is being tested in a number of countries. The FDA approved the drug, although it noted some "uncertainty" in the results of clinical trials. The FDA has asked the manufacturer to run additional tests that could take years.
Nakamura Harumasa, who leads clinical trials at Japan's National Center for Neurology and Psychiatry, says it is premature to approve the drug in Japan. .
“The efficacy of aducanumab has not yet been fully confirmed,” he says. I'm not ready to be happy. It needs to be carefully checked to see if the drug actually works and to whom it can be given.”
Other experts are also expressing concern. Among them is Iwatsubo Takeshi, Senior Director of the Japan Society for the Study of Dementia. He says the clinical evidence points to potential side effects, including localized brain swelling, headaches, and mild impairment of consciousness that needs to be monitored.
Iwatsubo is also concerned about the cost of the drug, which is about 56 thousand dollars per year per patient. He says that this could create a serious financial burden on the government.
"I believe that only those patients who will benefit from it should receive the drug," the specialist is sure.
The drug's market name is Aduhelm. It destroys protein plaques that form between brain neurons and lead to cognitive impairment. The US Food and Drug Administration (FDA) approved the new drug in early June, after results from clinical trials showed it could slow the progression of Alzheimer's disease when taken early enough.
The Japanese Ministry of Health has been considering an application for approval of the drug since December last year. Some experts are unsure of the drug's effectiveness, and worry about the cost and how quickly it got approved in the US. Alzheimer's sufferers, their families and caregivers are cheering the new drug.
“We are full of hope because the drug has been approved in the US for the treatment of pathology. I really hope it gets approved in Japan soon,” says Mori Yoshihiro, who leads a support group for early-onset Alzheimer's patients and their families.
“Patients have been disappointed many times Mori.
About six million people in Japan have dementia, and it is estimated that about 60% of them have Alzheimer's disease. This figure is likely to rise as Japanese society ages. Iwasa Marie cares for her mother, who developed early onset of Alzheimer's disease. She says that dementia is a cruel test for both the patients themselves and their families. Her mother, now 72, was diagnosed at 58. Since then, her condition has been deteriorating inexorably, and now she can barely even remember her daughter's name.
“I often feel despair, realizing that this disease is incurable. It’s unspeakably hard just to watch my mother fade away,” says Iwasa. “I don’t wish any family to experience what we had to endure.” Iwasa Marie showed a photo of her mother’s blank expression and wrote about the shock she experienced when she realized that she barely recognizes her.
Biogen is already distributing the drug in the United States, and it is being tested in a number of countries. The FDA approved the drug, although it noted some "uncertainty" in the results of clinical trials. The FDA has asked the manufacturer to run additional tests that could take years.
Nakamura Harumasa, who leads clinical trials at Japan's National Center for Neurology and Psychiatry, says it is premature to approve the drug in Japan. .
“The efficacy of aducanumab has not yet been fully confirmed,” he says. I'm not ready to be happy. It needs to be carefully checked to see if the drug actually works and to whom it can be given.”
Other experts are also expressing concern. Among them is Iwatsubo Takeshi, Senior Director of the Japan Society for the Study of Dementia. He says the clinical evidence points to potential side effects, including localized brain swelling, headaches, and mild impairment of consciousness that needs to be monitored.
Iwatsubo is also concerned about the cost of the drug, which is about 56 thousand dollars per year per patient. He says that this could create a serious financial burden on the government.
"I believe that only those patients who will benefit from it should receive the drug," the specialist is sure.
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