The United States Approves Breakthrough Alzheimer’s Drug

Alzheimer's has no known cure. Image: Shutterstock

The United States Approves Breakthrough Alzheimer’s Drug.

The Food and Drug Administration (FDA) said that it acknowledged that the drug treatment “left residual uncertainties regarding clinical benefit,” but concluded that “the benefits outweigh the risks” of the therapy, according to a report from France 24.

The drug’s approval has been accelerated because, according to the FDA, it provides a “significant therapeutic advance” compared to other treatments by reducing the “beta-amyloid” plaques in the brain, which are a sign of the disease. The administration considers the drug offers significant benefits to those affected.

“Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid-beta plaques in the brain,” said the FDA’s Patrizia Cavazzoni.

The treatment takes the form of an infusion, will be available, and note the FDA said Biogen must conduct a post-approval clinical trial to verify the drug’s clinical benefit. It will be sold under the brand name Aduhelm.

A confirmatory diagnosis of Alzheimer’s disease is key to ascertaining if aducanumab is a treatment option for individuals. Patient diagnosis itself can be difficult, currently requiring a PET scan and/or a cerebrospinal fluid (CSF) test, alongside memory tests and followed by careful clinical assessment.

One theory holds that Alzheimer’s disease comes from an excessive accumulation of these proteins in some people’s brains as they age and their immune systems decline.

Providing such patients antibodies could therefore be a means to restore some of their capacity to clear the plaque buildup.

It is important that healthcare systems and regulators are able to respond to the need and demand for this treatment to ensure that people living with dementia can benefit from aducanumab and more importantly do not face any unnecessary delays in accessing treatment.

In Spain, more than 800,000 people are living with Alzheimer’s. Worldwide, at least 44 million people are living with dementia, making the disease a global health crisis that must be addressed.


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Written by

Ron Howells

Ron actually started his working career as an Ophthalmic Technician- things changed when, during a band rehearsal, his amplifier blew up and he couldn’t get it fixed so he took a course at Birmingham University and ended up doing a degree course. He built up a chain of electronics stores and sold them as a franchise over 35 years ago. After five years touring the world Ron decided to move to Spain with his wife and son, a place they had visited over the years, and only bought the villa they live in because it has a guitar-shaped swimming pool!. Playing the guitar since the age of 7, he can often be seen, (and heard!) at beach bars and clubs along the length of the coast. He has always been interested in the news and constantly thrives to present his articles in an interesting and engaging way.


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