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What is known about the new US agency-approved Alzheimer's drug

Publicado em 15 junho 2021

Por Lyncon Pradella

The federal agency of United States, Food and Drug Administration (FDA), sparked controversy after approving, on June 7, the first drug against Alzheimer's in nearly two decades. So far, what do we know about this new drug that raises questions among doctors and experts?

With a limited evidence base, plus several breaks and starts in its development and approval process, the drug, called aducanumab, will be branded and sold as Aduhelm.

Involved in the drug's clinical development, Dr. Stephen Salloway, a professor of neurology and psychiatry at Brown University, explained that he is a strong believer in the drug's potential.

“I truly believe this ushers in a new era in the fight against Alzheimer's disease,” said Salloway, who has directed the Butler Hospital's Memory and Aging Program and has researched Alzheimer's disease for 30 years.

Salloway was also Butler's principal investigator for the Phase 1 and Phase 3 trials of aducanumab, co-chairs the Phase 3 program's investigative steering committee, and advised drug manufacturer Biogen on safety protocols and effect management collateral.

On the medical studies website, Medical Xpress, Dr. detailed the differences between aducanumab and other Alzheimer's treatments. "It's important to know that this is the first drug to target a central component of Alzheimer's disease: amyloid plaques that play a key role in memory loss," he said.

“Aducanumab is a monoclonal antibody made from immune cells from elderly people without cognitive decline or unusually slow cognitive decline. It binds to the amyloid plaques and breaks them up. The other Alzheimer's drugs focus on neurotransmitters; they alter different chemicals in the brain to help improve functioning, but they don't really address the underlying pathology of the disease.”

Regarding the questions from colleagues in the profession about the drug's approval, Salloway said he understood the doubts, but believed that the seriousness of the condition favored an accelerated approval by the FDA.

“I support the FDA's requirement for the additional study to confirm the positive results. I think it's the right thing to do. I think they're trying to strike a balance between making this treatment available for a devastating disease without having to wait another five years, but also requiring more data and careful monitoring of patients. This approval, in my opinion, will speed up Alzheimer's research”, he concluded.

Alzheimer's increases chance of death by Covid-19 three-fold: study

The main reason for the accelerated approval of aducanumab is the Covid-19 pandemic. That's because Alzheimer's can increase up to three times the risk of death by the coronavirus.

The results were shown in an article published in the journal “Alzheimer's & Dementia: The Journal of the Alzheimer's Association”, in April, with the support of FAPESP, Faperj and CNPq.

In addition to increasing the chance of death, Alzheimer's has also been shown to have a higher Covid-19 infection rate in patients over 80 years of age. In general, this condition is found in people with neurodegenerative diseases, even if they receive treatment.

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