The US Food and Drug Administration has approved Biogen’s aducanumab, the first drug to target an underlying cause of Alzheimer’s disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer’s drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
Context
The US Food and Drug Administration has approved Biogen’s aducanumab, the first drug to target an underlying cause of Alzheimer’s disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer’s drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
Alzheimer's disease
- Alzheimer's disease is the most common type of dementia.
- It affects tens of millions of people worldwide, and this number is rising dramatically.
- The social and economic burden of Alzheimer's disease is high.
- Forgetfulness and memory problems are often early symptoms, but as the illness progresses, patients tend to become confused, may lose their way around familiar places, and have difficulties with planning and completing simple tasks.
Cause
- The amyloid hypothesis proposes β-amyloid (Aβ) as the main cause of the disease.
- It suggests that misfolding of the extracellular Aβ protein accumulated in senile plaques and the intracellular deposition of misfoldedtau protein in neurofibrillary tangles cause memory loss and confusion and result in personality and cognitive decline over time.
- Accumulated Aβ peptide is the main component of senile plaques and derives from the proteolytic cleavage of a larger glycoprotein named amyloid precursor protein (APP).
- APP is a type 1 membrane glycoprotein that plays an important role in a range of biological activities, including neuronal development, signaling, intracellular transport, and other aspects of neuronal homeostasis.
- Several APP cleavage products may be major contributors to Alzheimer's disease, causing neuronal dysfunction.
Cases
- According to World Health Organization (WHO) estimates for 2017, dementia affects approximately 50 million people worldwide, a number that is projected to grow to 82 million by 2030.
- In India, it is estimated that 5.3 million people (1 in 27) above the age of 60 have dementia in 2020, according to the Dementia in India 2020 report published by the Alzheimer’s and Related Disorders Society of India.
- This is projected to rise to 7.6 million by 2030.
The drug
- The drug aducanumab, with brand name Aduhelm, is a monoclonal antibody that is designed to reduce the presence of amyloid beta.
- The drug is to be given as a monthly intravenous infusion.
- In clinical trials, some patients given the highest dose of the drug experienced brain swelling and had to be monitored.
- Headache is also a reported side effect of the drug.
- It is a novel drug that is designed only to slow the progression of Alzheimer’s and not a cure.
Parkinson’s Disease
- Parkinson’s disease (PD) was described by James Parkinson nearly 100 years before Dr. Alois Alzheimer described the dementia later named Alzheimer’s disease (AD).
- Called the “shaking palsy” by Parkinson, PD is diagnosed when a person shows at least two of these three symptoms: slowed movements (bradykinesia), muscle rigidity, and tremor (at rest).
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