FDA Has Approved A New Drug For People With Alzheimer’s Disease

FDA Has Approved A New Drug For People With Alzheimer’s Disease

Alzheimer’s disease is commonly referred to as Alzheimer’s, which is a neurodegenerative disease that usually starts slowly and progressively worsens. In most cases, about 60% to 70% of the cases end up in dementia. The most common symptom is difficulty in remembering recent events.

FDA Has Approved A New Drug For People With Alzheimer’s Disease

As the disease worsens gradually, people with dementia will have difficulty or problems with language, disorientation which includes easily getting lost, mood swings, loss of motivation, self-neglect, and behavioral issues. As the condition of the person worsens, the person drifts away from friends and family and gradually, bodily functions are lost, which ultimately leads to death.

FDA Has Approved A New Drug For People With Alzheimer’s Disease

As per the reports, some of the major signs and symptoms basically start in the early stages. There are three stages in the diagnosis. One is Early stage, the Middle stage, and the Late stage. The course of Alzheimer’s is generally described in three stages, with a progressive pattern of cognitive and functional impairment. The disease is known to the hippocampus which is associated with memory, and it is responsible for memory impairment. As the disease worsens so does the degree of memory impairment.

It is also believed that the disease will occur when abnormal amounts of amyloid-beta, accumulating extracellularly as amyloid plaques, and tau proteins, accumulating intracellularly as neurofibrillary tangles, form in the brain affecting neuronal functioning and connectivity, resulting in a progressive loss of brain function. This is altered protein clearance ability is age-related and is associated with other neurodegenerative diseases.

From the previous data available, there were no treatments or medications available. But as per the recent data, it is observed that the Food and Drug Administration approved the first new Alzheimer’s drug in nearly 20 years. It is also mentioned that while the data on the drug left some uncertainties, the Food and Drug Administration concluded that it could lead to important health benefits.

The reports also show that the Food and Drug Administration approved a new drug for Alzheimer’s disease, and this drug approval has been the first since 2003. In the statement, it was also mentioned that Biogen’s drug Aduhelm treats patients with Alzheimer’s disease using the accelerated pathway, the regulator stated. It was also stated that the Food and Drug Administration once approves the drug for a serious or life-threatening illness, it will be used to provide meaningful therapeutic benefit over the existing treatments and the drug has shown the result that is likely to predict a benefit to patients despite some uncertainty about the drug’s clinical benefit.

The reports also stated that since the decision is this significant, it also comes with some controversy and some Alzheimer’s experts and an independent advisory committee have opposed the approval and usage of the dug which is known as aducanumab. The Food and Drug Administration stated that to determine whether the drug meets all the requirements for the accelerated approval, the agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risk of the therapy. 

The Food and Drug Administration also stated that taking all of these into consideration, it is well aware of the attention surrounding this approval, and the also mentioned that given the seriousness of Alzheimer’s disease, it makes sense that so many people were following the outcome. The regulator also mentioned that the data which was in the review was highly complex and left residual uncertainties regarding the clinical trials.

The agency also stated that there has been considerable discussion regarding the approval of the drug Aduhelm. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.

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