US approves new Alzheimer's disease medication



The US Food and Drug Administration granted approval to a much-anticipated new medication on Friday in order to reduce cognitive deterioration in people with moderate and early-stage Alzheimer's disease.


Leqembi, also known as lecanemab, has been approved by the FDA just days after the regulatory body received strong criticism for approving Aduhelm, another medication for Alzheimer's.And despite trial results showed that using a monoclonal antibody to treat patients includes risks of brain haemorrhage and edoema, the approval was given.
The FDA was able to expedite the approval of these two medications since they were intended to treat serious illnesses for which there is an unmet medical need.
The FDA stated in a statement that Leqembi and Aduhelm, which were jointly developed by American Biogen and Japan's Eisai, "represent an important advancement in the ongoing struggle to successfully treat Alzheimer's disease."

The Cost Of Drugs



According to Billy Dunn of the FDA's Center for Drug Evaluation and Research, "Alzheimer's disease has devastating consequences on the lives of those who suffer from it and greatly incapacitates those who suffer from it."Leqembi is "the most recent medication to target and influence the underlying disease process of Alzheimer's, rather than only treating the symptoms of the disease," according to Dunn.Alzheimer's disease, which is characterised by memory loss and deteriorating mental sharpness, affects around 6.5 million Americans.

Leqembi showed a 27% reduction in the rate of cognitive loss in Alzheimer's patients, according to preliminary results from a trial that were published in September.
Over the course of 18 months, the phase three trial included roughly 1,800 participants who were split between receiving the medicine and a placebo.
The full trial results, which were published in the New England Journal of Medicine, prompted questions about the frequency of "adverse events," such as brain enlargement and bleeding, among other things.


According to the findings, brain bleeding occurred in 17.3% of patients who received the medication compared to 9% of those who received a placebo.Additionally, 12.6% of those taking the medication had brain edoema, as opposed to 1.7% of those receiving a placebo.
In both arms of the drug trial, deaths were reported at roughly the same rates.

$26,500 a year

Drugs Is Damage To Health


In Alzheimer's disease, two essential proteins, tau and amyloid beta, accumulate form tangles and plaques, collectively known as aggregates, which result in the death of brain cells and subsequent brain atrophy.
Targeting amyloid is how leqembi, which is given intravenously once every two weeks, functions.In the study, patients using Leqembi experienced a statistically significant decrease in brain amyloid plaque as compared to those taking a placebo, who experienced no such decline.Aduhelm was formerly marketed by Biogen and Eisai, however there was considerable debate over its efficacy, and its approval in 2021 resulted in three high-level FDA resignations.



The Alzheimer's Association's president and CEO, Joanne Pike, hailed Leqembi's clearance but voiced concern that it may be too expensive for the majority of Americans, particularly if it is not covered by Medicare, the federal health insurance programe for the elderly.
People who are currently afflicted by this terrible illness do not have the luxury of waiting for a miraculous medication or treatment, according to Pike.