The European Medicines Agency has accepted Biogen’s Marketing Authorization Application (MAA) for review. The application is for aducanumab, a treatment for Alzheimer’s disease. As this condition faces an unmet medical need, the approval of this application would mean that patients finally have access to a therapy that can reduce the clinical decline that characterizes Alzheimer’s.
Aducanumab is a human monoclonal antibody that targets the underlying cause of the disease in order to slow progression and provide other benefits. Clinical data from the Phase 3 EMERGE and ENGAGE trials has proven this treatment can improve the lives of Alzheimer’s patients by allowing them to to perform daily tasks, such as shopping, cleaning, laundry, chores, personal finance, and leaving the house.
This therapy is currently being reviewed by the FDA as well, meaning that patients in the United States may also have access to aducanumab soon. The application is being process with priority review, so approval may come sooner than later. As patients do not have many viable treatment options, hopefully this drug will be approved and able to improve lives.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive disorder that causes the degeneration and death of brain cells. It occurs in stages, with severity increasing as time goes on. In the later stages of the disease, people will experience significant memory loss and be unable to carry out everyday tasks. The major symptom of this condition is memory loss. Other issues that people experience include problems with thinking and reasoning, making judgments and decisions, planning and completing familiar tasks, and more. They will experience changes in personality and behavior. Other complications can also arise from Alzheimer’s, such as aspiration, pneumonia, infections, falls, fractures, bedsores, malnutrition, and dehydration.
Medical professionals believe that Alzheimer’s is caused by a combination of genetic, environmental, and lifestyle factors. What healthcare professionals do know is that brain cells deteriorate and die. They also suspect that plaques and tangles, which are both proteins, play an important role. There are risk factors that may heighten the chances of developing Alzheimer’s disease. Age is a major factor, as people usually develop this condition after 65. If one has a relative that is affected, they are also at a higher risk. Females are also affected at a higher rate than males. Those with past head trauma, poor sleeping patterns, poor exercise patterns, or other unhealthy lifestyle habits have a higher chance of Alzheimer’s disease.
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