Health
FDA Approves First Alzheimer’s Disease Treatment Can Slow Progression
The Food and Drug Administration (FDA) quickly followed Monday for approval of a new drug for Alzheimer’s disease for the first time in nearly 20 years, giving hope to patients with the disease and their families.
Biogen’s aducanumab, under the brand name Aduhelm, is the first drug to act to address the cause of the disease rather than treat the symptoms.
Jennifer Leopard, President and CEO Alzheimer’s Association Michigan Branch, “Until now, there was no cure to slow the progression of the disease.”
The association urged FDA approval, and other groups rallyed to delay approval of additional trials.
However, FDA Fast Track Approval Program, According to the FDA’s website, this “allows early approval of drugs that treat serious conditions and meet unmet medical needs based on surrogate endpoints.”
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Accelerated approval means that the FDA requires pharmaceutical companies to carry out post-approval research.
Some panelists and organizations have stated that the trials did not prove sufficiently effective for approval. Despite these oppositions, Lepard argued that the groundbreaking nature of the drug proved its value.
“This is the first drug to treat the underlying biology of the disease, and it really doesn’t make sense to not be able to provide it to people,” Leppard said.
“Gives a faint hope”
For Lansing’s 66-year-old Bertha Bullen, the sign of approval feels like a step in the right direction.
Bullen lost his mother, stepmother, and grandmother to Alzheimer’s disease. There are many other people in her family who have been diagnosed.
“I’ve been following the findings for quite some time,” Bren said. “It gives me some hope, but I’m a little cautious because these things don’t always work.
Aducanumab has shown to Bren that further research is underway, she said it makes her optimistic. This drug does not cure Alzheimer’s disease, but those who are diagnosed early Slows the progress of.
“It’s a gift to spend more time with people with dementia,” says Bullen.
Saline’s James Mangi, 73, has been caring for his 72-year-old wife, Kathleen Schmidt, since her diagnosis 14 years ago.
“My wife won’t benefit, but this is welcome news for me,” Mangi said, as Schmidt is in the late stages of Alzheimer’s disease.
Mangi, whose wife immediately smiles even if other abilities leave her, volunteers for the Alzheimer’s Association and runs. Dementia-friendly saline, A grassroots initiative aimed at making people with dementia and their caregivers a more inclusive city.
For him, the greatest value of aducanumab is its catalytic properties for further research and increased awareness of Alzheimer’s disease.
How does the drug work?
Alzheimer’s disease is the result of the accumulation of the protein amyloid, said Dr. Cara Leahy, director of cognitive impairment at the Memorial Healthcare Institute for Neuroscience. This accumulation ultimately leads to the death of nerve cells, which causes disease-related symptoms.
Aducanumab, a monoclonal antibody, targets the protein and slows the progression of the disease, Leahy said.
Dr. Jonathan Fellows, a neurologist at the Michigan Institute for Neurological Disorders, said aducanumab could sufficiently slow the progression of the disease and allow patients to benefit from more advanced treatment in the future.
However, as well as the unprecedented benefits of this drug, there were also unprecedented side effects. Amyloid-related image abnormality.
This side effect, known as ARIA, may appear in the first 8 infusions. They can be seen on MRI scans and cause symptoms such as mild swelling of the brain, changes in mental status, and headaches.
However, the fellows believed that the breakthrough potential of the drug outweighed the potential of ARIA.
“I think the FDA understood this correctly,” says Fellows.
aducanumab is not a pill, but an intravenous drip every 4 weeks.
Leahy said: “Throughout my career, Alzheimer’s patients have asked me,’Is there anything new?’ I had to say no all the time, but now I have new options. “
The future of Alzheimer’s disease treatment
Mangi remembered what Neil Armstrong said when he set foot on the moon. “A small step for humankind, a big leap for humankind.”
That’s what aducanumab feels to him in the field of treatment of Alzheimer’s disease.
“This is a big step, because it’s really the first drug that works for anything. It doesn’t work, but if it works, there are incentives,” Mangi said.
“It could bring a new wave to the study of Alzheimer’s disease,” Leahy said.
“This is just the beginning of the whole wave of medicine.”
Minnah Arshad: Contact [email protected] and follow her on Twitter @minnaharshad.
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