FDA approved Aduhelm, the first new treatment for Alzheimer’s disease in nearly 20 years
On Monday, the US Food and Drug Administration approved the first new treatment for Alzheimer’s disease in nearly 20 years.
The drug, called Aduhelm, targets a toxic protein that damages neurons, rather than simply treating the symptoms of the disease. This damage is thought to cause the cognitive decline associated with dementia.U.S. Food and Drug Administration Cheers therapy As the first of its kind.
“Currently available therapies can only treat the symptoms of the disease; this treatment option is the first treatment that targets and affects the underlying disease process of Alzheimer’s,” said FDA Director Dr. Patrizia Cavazzoni. “As we have learned from the fight against cancer, accelerated approval pathways can bring treatments to patients faster, while stimulating more research and innovation.”
Biogen’s Aduhelm is designed to slow down cognitive decline. However, it cannot cure Alzheimer’s disease, nor can it reverse the progression of Alzheimer’s disease. Neurodegenerative Diseases???.
Although many people with Alzheimer’s This new treatment has been strongly advocated, but some scientists say there is insufficient evidence to prove the efficacy of this drug. Although FDA approved opposing view The attention of its own advisory committee and many external experts.
Others said that there is enough data to support the approval and point out that new treatment options are urgently needed. Approximately 6.2 million Americans have Alzheimer’s disease; of these, approximately 2 million have early-stage Alzheimer’s disease and will be eligible for treatment. Must be injected intravenously once a month.
“This FDA drug approval opens a new era in Alzheimer’s treatment and research,” Maria C. Carrillo, Chief Scientific Officer of the Alzheimer’s Association, said“History tells us that the approval of the first drug in the new category revitalized the field, increased investment in new therapies, and encouraged greater innovation. We are hopeful, and this is the beginning—whether for this Medicine is to better treat Alzheimer’s disease.”
For fear of insufficient evidence, the FDA only granted conditional market approvals. Biogen is expected to complete a large clinical trial to confirm the effectiveness of the drug in reducing toxic protein clumps called beta-amyloid.
The FDA’s decision was based on data from three studies, which included 3,482 participants. The treated participants showed a significant reduction in beta amyloid plaque accumulation, while patients in the control group showed no plaque reduction at all. Positron emission tomography imaging was used to measure plaque buildup.
However, the effect of the drug on cognitive decline is not clear.
After independent monitors determined that the drug was unlikely to benefit patients, the two phase 3 studies were discontinued in March 2019. But a new analysis released in October 2019 showed that in one of two studies, Aduhelm slightly slowed cognitive decline.
“For eligible patients, I am hopeful for them,” Dr. Ronald Peterson, director of the Alzheimer’s Research Center at the Mayo Clinic, told statistics“Now we have a potential treatment for them that may change the underlying disease process. But our biggest responsibility is to educate patients and doctors about what this means. This will not be the penicillin for Alzheimer’s disease.”
Aduhelm’s prescribing information will include warnings about potential temporary brain swelling, which can cause headaches, confusion, dizziness, nausea, and vision changes. This kind of brain swelling, headache, risk of falling, diarrhea, confusion or disorientation are the most common side effects.