First Alzheimer’s drug approved by FDA

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Aducanumab is the first drug for Alzheimer’s disease that recently received FDA approval. Aducanumab has got FDA approval on7th June 2021.  Biogen in Cambridge, Massachusetts has developed Aducanumab. Clinical researchers give their best effort to discover a treatment for Alzheimer’s disease. After 18 years medical industry welcomed this molecule with the hope to obtain a victory against neurodegenerative disease.

Alzheimer’s disease is a neurodegenerative disease condition with a complex etiology. This disease causes an irreversible deterioration of the physical and mental condition of the affected individual. The condition worsens over time by slowly destroying memory and thinking skills. Alzheimer’s disease affects the brain resulting in memory loss and cognitive impairment. It is an age-related disorder that mostly affects aging populations. People age 65 years or above are usually affected by Alzheimer’s disease. However, the “younger-onset” of Alzheimer’s disease, i.e. before the age of 65 years is also becoming prevalent.

Alzheimer’s Association reported that 5.7 million US populations of all age groups are affected by Alzheimer’s disease. Almost 200,000 Americans of this population are affected with “younger-onset” Alzheimer’s disease. One of the primary reasons for increasing prevalence is the improvement in the survival rate of aging people.  The fact sheet also mentions that one American is affected by Alzheimer’s disease every 65 seconds, and it has become the 6th major cause of mortality in the USA.

Alzheimer’s disease is a non-curable condition. It is progressive which requires palliative care for the affected individuals. In the USA, an individual having Alzheimer’s disease pays approximately $341,840 for his/her healthcare purpose. This cost burden negatively affects the whole nation. Experts assume that the medical cost for Alzheimer’s disease will be raised by almost $1.1 trillion by 2050.  Hence, it is high time to search for an effective and economic treatment for Alzheimer’s disease.

Biogen in Cambridge, Massachusetts is a biotechnology company. Aducanumab is different from other currently available Alzheimer’s drugs. Yet now available treatment medication can only provide symptomatic relief like delaying loss of memory by a few months. The researchers from Biogen have claimed that aducanumab could treat the possible underlying cause of neurodegenerative disease.

The mechanism of action of aducanumab is to clear out protein clumps in the brain called amyloid-β. According to the amyloid hypothesis, amyloid-β is the root cause of Alzheimer’s disease. The FDA approved this drug molecule because of its capability to reduce the levels of these plaques in the brain.

Aduhelm is the marketed name of the aducanumab. It is expected that this drug will generate huge revenue for the company. According to company news, Biogen decided the price list of aducanumab is $56,000 per year i.e. $4,312 per infusion.  Biogen CEO Michel Vounatsos vowed that the company would not hike its price for four years.

However, it is necessary to mention that other clinical researchers doubt the efficacy of this molecule. A medical expert team of neurologists and biostatisticians reported that the obtained clinical trial data did not provide the definite conclusion of slowing down cognitive decline with aducanumab treatment. But the FDA announced that continuous monitoring of the drug will continue even after the drug reaches the U.S. market. The agency approved on the condition that Biogen conducts another clinical trial.




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