Eduardo Ruman (In Memoriam)
Administrativo e Empreendedor
Denise Ruman
MTB - 0086489
The Biggest and Best International Newspaper for World Peace
Founder, President And International General Chief-Director / Fundadora, Presidente e Diretora Geral Internacional :  Denise Ruman - MTB: 0086489 / SP-BRAZIL
Local Chief-Director - Brazil / Diretora-Chefe Local - Brasil :  Denise Ruman
Mentor do Jornal / Mentor of the Newspaper  :  José Cardoso Salvador (in memoriam)
Mentor-Director / Mentor-Director  :  Mahavátar Babají (in memoriam)

Saúde / 07/06/2021


Alzheimer: FDA Approves New Treatment, First in 20 Years

0 votes
Alzheimer: FDA Approves New Treatment, First in 20 Years

Hope against Alzheimer's. The FDA, the drug regulatory agency in the United States, has just approved a new treatment for people with Alzheimer's. It is the first released in the last 18 years.

Approval was given this Monday, 7. The drug is aducanumab – trade name Aduhelm. It is manufactured by Biogen.

Treatment is with a monthly intravenous infusion to slow cognitive decline in people in the early stages of the disease, with mild memory and reasoning problems.

It embraces the Alzheimer's disease process rather than just treating the symptoms of dementia.

The approval came after pressure patient advocacy groups. They claim that there are few treatments available and other drugs in clinical trials, while more promising, will take three to four years to be approved.

how the medicine works

Aducanumab, a monoclonal antibody, targets a protein, amyloid, which clumps in plaques in the brain of Alzheimer's patients and is considered a biomarker of the disease.

One thing critics and proponents of approval agree on is that the drug substantially reduces amyloid levels, and F.D.A. said the drug's effect on a biomarker qualified it for the accelerated approval program.

Proponents of the approval also said it is possible that eliminating amyloid early could help control the disease in the future, providing additional benefits beyond the slightly delayed initial decline.

expensive medicine

The company hasn't announced a price yet, but it could range $10,000 (R$50,000) to $50,000 (R$250,000) per patient per year, Wall Street analysts project.

In other words, it will be an expensive medicine, which few people will have access to at first.

In the US, most costs are owed on Medicare's Part B program, which has yet to say how it will cover the drug and its associated costs.

Controversies over effectiveness

As clinical trials of the drug provided incomplete evidence to demonstrate efficacy, the F.D.A. granted approval on condition that the manufacturer, Biogen, conduct a new clinical trial.

Until then, the drug will be available to patients, the US agency said.

If the Phase 4 study does not prove the drug is effective, the F.D.A. may terminate its approval.

"There is so little evidence of effectiveness," said Dr. Lon Schneider, director of the California Alzheimer's Disease Center at the University of Southern California and one of many local researchers who helped conduct one of the aducanumab trials. He added: “I don't know what caught the F.D.A. on here."

Dr. Stephen Salloway, who participated in the studies, said that while he understands the concerns about the data, “the totality of evidence favors approval, and F.D.A. the approval will open the door to a new era of treatment for Alzheimer's disease that we can build on. ”

Side effects

The risks with aducanumab involve swelling or bleeding in the brain experienced by about 40 percent of Phase 3 trial participants who received the high dose.

Most were asymptomatic or had headaches, dizziness or nausea. These effects led 6% of high-dose users to discontinue treatment. No Phase 3 participant died the effects, but one safety trial participant did.

family approved

Henry Magendantz (pictured above) is a patient in the aducanumab trial. He has been receiving infusions since 2014.

His wife, next to him in the photo, believes the drug has slowed his decline enough to allow him to help choose an assisted living unit he now lives.

Medicine sales

Biogen hopes to launch the drug quickly, with more than 600 US locations expected to administer it.

About six million people in the United States and about 30 million worldwide have Alzheimer's, a number that is expected to double by 2050.

Currently, five drugs approved in the United States can delay cognitive decline for several months in various stages of Alzheimer's.

0 comentários

  • Enviar Comentário
    Para Enviar Comentários é Necessário estar Logado.
    Clique Aqui para Entrar ou Clique Aqui para se Cadastrar.

Ainda não Foram Enviados Comentários!

Copyright 2022 - Jornal Pacifista - Todos os direitos reservados. powered by WEB4BUSINESS

Inglês Português Frances Italiano Alemão Espanhol Árabe Bengali Urdu Esperanto Croata Chinês Coreano Grego Hebraico Japonês Hungaro Latim Persa Polonês Romeno Vietnamita Swedish Thai Czech Hindi Você