FDA authorizes drug for Alzheimer’s disease after approximately 20 years.
What is Alzheimer’s disease?
Alzheimer’s disease is a progressive neurologic ailment that causes the brain to wither and brain cells to perish.
It is the most common cause of dementia — a consecutive decline in thinking and behavioral skills that affect a person’s proficiency to function independently.
The US Food and Drug Administration (FDA) said there was “considerable evidence that aducanumab reduces amyloid-beta plaques in the brain and that it is quite feasible to predict important advantages to patients.”
How FDA approved Alzheimer’s drug, Aducanumab, works?
Aducanumab works by removing sticky deposits of a protein called amyloid-beta from the brains of patients in earlier stages of Alzheimer’s to beat back its damages.
Aducanumab branded as, Aduhelm, shows mixed results in clinical trials.
Some patients faced dangerous adverse effects such as, brain swelling.
But, according to FDA, it can removes amyloid protein that is beneficial for disease regression.
Aducanumab clinical trial:
In March 2019 clinical trial was curtailed because the drug was not showing any progression in slowing the memory deterioration.
Later, A US manufacturer, Biogen, picked up the study by analyzing more data and concluded that, the drug did work.
Wall Street analysts estimated peak annual sales for the drug ranging from $10 billion to $50 billion.
The decision is welcomed by many NGOs and Alzheimer’s society.
But, scientists and doctors are divided over the ruling.
They don’t consider it a miracle drug or a quick cure, although it may slow the progression.
Aldo Ceresa, who took part in clinical trials, said: ” I am quite happy to volunteer,” he says. “I enjoy this journey that I’m going through – and the benefits I’m getting from it, which I’m very, very grateful for it”
The drug will initially be made available only for a very specific number of patients, mostly ageing from the 60s to 70s, after confirming certain brain scans.