- Sejal Kakkar
One of the leading causes of dementia in older adults, Alzheimer’s disease (AD) is an irreversible neurological disorder. It is a progressive condition and its increasing incidence is a function of time. With over five million cases being diagnosed every year and its prevalence roughly doubling every five years, AD has been a concern to millions worldwide.
Over the years, studies have proven that the fundamental abnormality in AD is the accumulation of two proteins, beta-amyloid (Aβ) and tau, in specific regions of the brain. Excessive production of Aβ peptides followed by its defective removal, due to various genetic and host factors, leads to the formation and deposition of amyloid plaques- an important aspect of AD pathogenesis.
Major Pathological Hallmarks of AD
Initial symptoms of AD include forgetfulness which first becomes noticeable at around the age of fifty. As the disease progresses, deficits in memory, judgement and language gradually appear over 5-10 years; in the final stages of the disease, the affected individual can become profoundly disabled, mute and immobile.
For the first time in nearly two decades, the U.S. Food and Drug Administration ( FDA) has approved a drug for the treatment of this mind-robbing disease. Though highly anticipated by millions of diagnosed patients worldwide, the approval of Biogen’s Aducanumab (now known as Aduhelm) on a conditional basis could have some serious implications.
Aduhelm is a monthly intravenous infusion that acts on the underlying cause of the disease. Where previously known drugs treat the symptoms, Aduhelm mainly works by acting on the fundamental abnormality- producing antibodies that target Aβ plaques deposited in the brain. However, the approval of this drug has been termed as “one of the most controversial decisions made by the FDA”. There is insufficient data to prove the drug’s efficacy, and statistics from the Phase III clinical trial project provide only weak evidence of its cognitive benefits. The drug showed sufficient efficacy, however, in high doses. Aduhelm’s affordability has also been a concern for innumerable patients willing to seek it. Costing $56,000 per year, the price tag will pose a barrier to its accessibility.
The divergent outcomes of the Phase III clinical trials signify that the approval of Biogen’s Aduhelm is rather conflicting. This leaves us with a pressing question - could the approval of Aduhelm be a hasty decision by the FDA?
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