FDA grants full approval to Alzheimer's disease medication 'Leqembi'

The medication is approved for people suffering from mild dementia and other signs of early Alzheimer's disease. 

The approval by FDA

Following the review of the clinical trial data, authorization for the public use of Leqembi was given. 

In January, the FDA granted Eisai conditional approval under its Accelerated Approval pathway, which authorizes the approval of certain treatments when there is an "unmet medical need" based on early trial results. 

The medicine was effective to reduce brain plaque that mark the progression of the disease in the initial study. 

However, the FDA granted final permission only after a large-scale study that enrolled 1,800 participants. All of these patients were diagnosed with moderate cognitive impairment or mild dementia. 

​The Leqembi treatment is injected into the brain every two weeks.

According to the findings of this experiment, the medicine was able to reduce memory and thinking decline by around five months. 

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” added Buracchio. 

However, the treatment caused several negative side effects in a few patients, such as brain bleeding and edema.

How does the drug work?

This medication works by decreasing amyloid plaques that develop in the brains of Alzheimer's patients. It decreases amyloid beta, a protein that forms plaques and kills brain cells. 

Amyloid plaques are aberrant proteins that develop between nerve cells in the brain. These brain regions are responsible for memory and other cognitive tasks.

Alzheimer's disease is a fatal, irreversible neurological disorder that affects the lives of millions of individuals in the United States alone. 

As the condition proceeds, it impairs a person's capacity to think and results in loss of memory. They also lose their capacity to execute simple day-to-day tasks with time.

The therapy will be made available to the public through government-run health insurance for elderly citizens.

The approval is a glimmer of hope for those suffering from this devastating disease as well as their families. 

Meanwhile, new clinical trial data for another Alzheimer's treatment, donanemab, are also due in the coming weeks. In the near future, medical advancement will improve the living conditions of individuals with this life-threatening disease.