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FDA approves conditional trial for Alzheimer’s drug: A Silver Lining.

In a huge breakthrough, America’s Food and Drug Administration (FDA) has sanctioned conditional approval to a brand new drug, aducanumab, which is to be marketed under the name Aduhelm, for the treatment of Alzheimer’s disease. Alzheimer’s is a remorselessly degenerative disease, which eventually leads to extreme helplessness, not only for the patients but also for those who take care of them. This breakthrough approval of the FDA might give them a ray of hope. The benefits of this drug are yet to be revealed and the decision taken by the FDA is controversial as well.

About Alzheimer’s

A German psychiatrist named Alois Alzheimer discovered this disease 115 years ago. He conducted an autopsy that helped him in identifying the disease which is now known by his name. This illness is one of the common cause (among several others) of dementia (memory disorder, personality changes). This illness accounts for almost 60-80% of a severely weakening condition that affects around 50 million people all over the globe. As the risk of dementia is directly proportional to age (increases with age), with the world population growing older, this disease is spreading superfast. The cost of caring for people with this particular condition is estimated at around $1 trillion presently, and this cost is expected to reach $2 trillion within 8-9 years (2030). The price of human suffering is inestimable.

Even if few have anticipated for an immediate cure, there remains a great unmet need for a medication that at the very least slows the progression of Alzheimer’s disease. “Aduhelm is the first medication addressed at the fundamental pathophysiology of Alzheimer’s disease,” the FDA asserts in a press release about Biogen, a biotechnology company based in Cambridge, Massachusetts. Oligomannate (gv-971), a medication developed by Green Valley, a Shanghai-based business, received provisional clearance from China in November 2019. Western scientists, on the other hand, complained that the Chinese study’s data was sparse and that its conclusions were difficult to believe.

So it’s reasonable that some people are ecstatic about Biogen’s victory. However, it is not universal, in part due to the drug’s arduous path to approval. It’s a monoclonal antibody, which is a specialised protein molecule that’s part of the immune system that’s been tailored to bind to a protein called beta-amyloid, which forms plaques in the brains of people with Alzheimer’s disease and which many researchers have long suspected isn’t just a symptom but at least part of the cause (the “amyloid hypothesis”).

Aducanumab appears to decrease the quantity of beta-amyloid in the brain. That is why the FDA has given its approval. According to the notion, this will decrease the progression of cognitive decline. The evidence is less conclusive on this point. The FDA’s permission authorises the drug to be used, but it also requires Biogen to do a large-scale clinical research to establish that it works, and it cautions that if it doesn’t, it may be taken off the shelves.

Previous attempts to prove its efficacy seem to have failed in March 2019, when Biogen and Eisai of Japan announced the termination of two clinical trials involving persons with moderate cognitive impairment or early-onset Alzheimer’s disease. The evidence suggested that Aducanumab had no impact, hence it failed a “futility test.” Then, in October of that year, Biogen said that “patients…experienced significant improvement on measures of cognition and function such as memory, orientation, and language,” based on a new analysis of the data.

Higher doses of the medicine did have a minor but detectable benefit in decreasing cognitive loss in persons with Alzheimer’s disease, according to one of the two trials. After all, Biogen stated that it would seek FDA approval.

A medicine that was prescribed to even a small percentage of persons with dementia would be one of the best-selling drugs of all time. Biogen’s stock price, which had dropped about 30% on the day it announced the studies had failed, rebounded almost as much when the company reversed its mind, and climbed again a year later when the FDA made positive comments, as well as after its announcement on June 7. Aducanumab, which is given intravenously once a month at a clinic, is expected to cost thousands of dollars per year at first, and patients will need ongoing monitoring as many develop brain oedemas.

Many experts are sceptical of aducanumab in particular, as well as the amyloid theory in general. On the basis of the research presented, ten out of eleven members of an FDA-appointed expert advisory council voted against approving the medicine last November (the 11th was undecided). More recently, a new analytical study of various clinical studies published in Alzheimer’s & Dementia, the journal of the Alzheimer’s Association, a charity, found “incredible evidence of absence of an effect of anti-amyloid therapy in general,” by one of the authors of the report, Edo Richard, a Dutch neurologist. Dr. Richard thinks it’s “extraordinary” that the FDA overruled its own advisory panel to reach the drug’s “scientifically dubious” decision.

His report contends that the time has come to shift therapeutic efforts away from beta-amyloid-clearing medicines and onto new research avenues. Despite the scepticism surrounding this medicine, several experts in the area are optimistic that significant progress is being made in the fight against dementia. According to Jonathan Schott, a professor of neurology at University College London’s Dementia Research Centre and the chief medical officer of Alzheimer’s Research, 30-40% of dementia causes are controllable. There is already evidence that the age-specific risk of dementia is decreasing in the West as people live better lives: obesity, smoking, high blood pressure, and excessive drinking are all linked to a higher risk of dementia in middle age. From 1988 to 2015, a research published in Neurology monitored over 50,000 patients across America and Europe. It was discovered that 8.6% of the people had dementia. However, the odds of being one of them has dropped by an average of 13% over the previous decade, from around one-in-four for a 75-year-old in 1995 to fewer than one-in-five today.

In the meantime, significant progress has been achieved in the diagnosis of dementia. Previously, this required cognitive testing followed by an expensive brain scan or invasive lumbar puncture, but now a simple blood test can determine how likely someone is to acquire Alzheimer’s later in life decades in advance. Early detection of those at risk means that existing medicines, such as aducanumab, which is mostly ineffective once symptoms have progressed, could be used to make a difference.

And, with time, new treatments should become available. Professor of cognitive neurology at Cambridge, James Rowe, says dementia research has reached a “tipping point.” Rare hereditary disorders such as Huntington’s illness and frontotemporal dementia are expected to be the first achievements, according to him. Alzheimer’s disease, which could turn out to be a catch-all phrase for a range of distinct contributory illnesses that are treated differently, would come later. Alzheimer’s patients have had few reasons to be hopeful. Big pharma and government-funded researchers will take notice. Aducanumab is a minor step forward; greater ones are on their way.

As India’s population ages, the number of people affected by dementia and Alzheimer’s is estimated to be 7.6 million by 2030, this breakthrough might be an upcoming solution to this misery.

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Sanjana Simlai

Hey, this Sanjana. Am from Kolkata. Reading, writing and travelling have always attracted me. I am always ready to learn and look forward to opportunities that would enhance my career in Journalism. I spend my free time in clicking pictures with my Nikon DSLR and I find solace in poetry.

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