The FDA Just Opened Up Access to a Promising New Alzheimer's Drug
Visualization of synaptic transmission. (iLexx/Getty)
The latest Alzheimer's medication has been granted complete endorsement by the United States pharmaceutical controlling authority on Thursday. This decision facilitates greater accessibility to the general population through publicly funded healthcare schemes specifically designed for senior citizens.
Leqembi, created through collaboration between Eisai from Japan and Biogen from the United States, has proven to have a slight impact on slowing down the decline of cognitive abilities among individuals in the initial phases of the illness, according to findings from a clinical study.
However, the research also sparked worries regarding adverse outcomes such as cerebral hemorrhages and inflammation.
Leqembi received initial approval from the Food and Drug Administration in January under the category of "accelerated approval". As a result, the government-operated Medicare program for individuals aged 65 and above did not provide extensive coverage for it.
In light of additional research on the medication, Medicare has made a ruling on Thursday that it will now cover a significant part of the treatment costs. The original price set by the manufacturers was $26,500 per year.
"This corroborative research has substantiated that it is a secure and efficient therapy for individuals suffering from Alzheimer's disease," stated Teresa Buracchio, a senior representative from the FDA.
Chiquita Brooks-LaSure, the head of the organization overseeing Medicare, stated: "This is great news for the countless individuals in our nation and their loved ones who are impacted by this incapacitating illness."
However, individuals enrolled in Medicare will still be required to pay 20 percent of the expense, which could amount to thousands of dollars.
Roughly 6.5 million individuals in the United States endure the effects of Alzheimer's disease, distinguished by the deterioration of memory and mental sharpness.
Leqembi, or lecanemab, is a form of antibody therapy administered to the brain every fortnight. Its role is to diminish the presence of amyloid beta, a protein that aggregates into plaques and leads to the deterioration of brain cells, ultimately resulting in brain shrinkage.
Patient organizations expressed their appreciation for the FDA's ruling.
"The usage of this therapy, although not providing a solution, has the potential to grant individuals in the initial phases of Alzheimer's disease with extended periods to uphold their autonomy and engage in activities they hold dear," expressed Joanne Pike, President and CEO of the Alzheimer's Association.
This allows individuals to have additional months of acknowledging their spouse, offspring, and grandchildren.
Leqembi, produced by a collaboration between Eisai and Biogen, obtained approval as the second medication for Alzheimer's disease. The initial drug, Aduhelm, faced intense controversy upon its approval in 2021 due to inconsistent evidence regarding its effectiveness.
In the month of May, Eli Lilly, a pharmaceutical company from the United States, made an announcement regarding their drug donanemab. They stated that this medication has the ability to considerably reduce the decrease in cognitive function related to Alzheimer's disease. Furthermore, Eli Lilly revealed their plans to seek approval for the drug from regulatory bodies worldwide in the near future.
According to the Alzheimer's Association, a substantial majority of dementia cases, ranging from 60 to 80 percent, are attributed to Alzheimer's disease. This condition gradually diminishes cognitive abilities and recollection, ultimately depriving individuals of their capability to successfully perform even the most basic activities.
