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FDA approves the first Anti-Alzheimer’s drug in two decades but mired in controversy

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Kamal Saini
Kamal S. has been Journalist and Writer for Business, Hardware and Gadgets at Revyuh.com since 2018. He deals with B2b, Funding, Blockchain, Law, IT security, privacy, surveillance, digital self-defense and network policy. As part of his studies of political science, sociology and law, he researched the impact of technology on human coexistence. Email: kamal (at) revyuh (dot) com

The US FDA has just given the go-ahead for aducanumab. It is the first specific drug for Alzheimer’s to be approved since 2003 and, despite the good news that this implies, the regulator’s OK has been surrounded by controversy.

It is not a revolutionary drug, but its approval (and everything around it) tells us a lot about how the fight against the great neurodegenerative disease of our time is. What about aducanumab?

Two decades of crossing the desert

Alzheimer’s disease is the most common cause of dementia in the West and accounts for between 60 and 80% of all dementias. For this very reason, we are convinced that it will continue to grow hand in hand with the progressive ageing of the population throughout the world. If estimates are not wrong, the number of people with this disease will triple in the coming years. Today, according to the FDA, it is already “the sixth leading cause of death in the U.S.”

But, despite the fact that the disease is one of the (research) topics of our time and hundreds of laboratories around the world explore different lines of work, new drugs have resisted tooth and nail over the last few decades. Today, there are more than 130 clinical trials underway that have not yet achieved positive results.

What is Aduhelm (aducanumab)? 

It is a monoclonal antibody directed against beta-amyloid that is behind the senile plaques characteristic of the disease. Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system and have a very important role in the treatment of cancer or autoimmune diseases.

Biogen, the laboratory behind aducanumab, began developing it in 2015, and over the years, development has been so bumpy that trials were canceled two years ago. This same November, the FDA rejected its approval.

And the (much discussed) clinical trials showed that patients who received the treatment experienced a significant reduction in beta-amyloid plaque; while the patients in the control group had no reduction. Finally and in the face of “an urgent need for treatments”, the drug has obtained accelerated approval for patients with Alzheimer’s in early-stage (and who experience mild cognitive impairment).

Dosage, Price, and Approvals 

According to technical documents, aducanumab is administered intravenously once a month. In the US, each of these infusions will cost about $ 4,312. In Europe, the EMA admitted the drug for study at the end of 2020 and it is expected that we will soon have the decision on the table.

Will aducanumab change anything? 

Beyond the efficacy of the drug (which, if the data are correct, could help many mild cases of the disease and delay its progression), the truth is that the main effect of aducanumab will be the stimulus it is causing in the development of drugs. A bad streak of two decades has been broken, it is time to make up for lost time using all available technologies.

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