Alzheimer's drug approval optimistic amid promising results
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Following clinical trial results, another Alzheimer's drug proven to slow cognitive decline is one step closer to US approval.
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A sign for Eli Lilly & Co. outside their headquarters in Indianapolis on April 26, 2017. (AP)
As a consequence of clinical trial findings that were published in a reputable publication on Monday, a second Alzheimer's medication that has been shown to reduce cognitive loss moved one step closer to US approval.
After years of little advancement in the field, many experts have welcomed the results as significant advances. However, others have advised caution, characterizing the advantages as limited while highlighting the high prices and risks of life-threatening side effects.
A study published in the Journal of the American Medical Association (JAMA) found that the medicine donanemab reduced the progression of symptoms over an 18-month period by 35% in comparison to placebo in approximately 1,200 persons with early-stage Alzheimer's disease.
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Results from cognitive tests and participants' capacity to complete daily tasks were used to gauge this. Drugmaker Eli Lilly, which said it anticipates regulatory action in the United States by the end of the year, produces the medication, which is administered intravenously every four weeks.
The release of the new research coincides with the US Food and Drug Administration's decision to allow Leqembi, a medication created by Biogen and Eisai, to be covered by Medicare, the nation's sponsored insurance program for the elderly.
Both function by focusing on the protein amyloid beta, which damages cognition when it builds up in the brain.
"These first-generation drugs are by no means perfect, but represent an important breakthrough," interim director of the UK Dementia Research Institute, Giles Hardingham, said in a statement.
However, he added that it was equally crucial to understand that Alzheimer's is a complex illness and that amyloid beta was merely one factor in its development.
However, Eric Widera of the University of California, San Francisco, and colleagues argued that it was too early to conclude that the new medications would be helpful in the long run. Such opinions appeared in an editorial that was published alongside the new results in JAMA.
They claimed that Donanemab and Leqembi, also known as lecanemab, do not treat Alzheimer's disease but rather cause "slightly less worsening" in patients.
"The modest benefits would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. However, they are none of these," the authors wrote.
Patients will still be responsible for thousands of dollars in out-of-pocket expenses even after Medicare covers 80% of the expenditures.
Additionally, three deaths that were most likely brought on by the therapies that cause brain bleeds occurred in the investigations of donanemab and Leqembi.
Given that anti-amyloid therapies also speed up brain atrophy, research indicates that it will be critical to gather more information as the treatments enter the real world to determine whether they continue to decrease cognitive decline past 18 months or if they have the opposite effect.
Additionally, since 96% of the patients in the donanemab trial were white despite the fact that Black and Latino persons had a much greater prevalence of Alzheimer's, this means that important demographics still remain understudied.
