Toni Dimaano Science 01.06.2023 23:Jan PM EST

New Alzheimer's Drug Leqembi Gains Accelerated Approval From The FDA

Leqembi (lecanemab-irmb), a medication for the treatment of Alzheimer's disease, has just received approval from the US Food and Drug Administration through the Accelerated Approval pathway.

Despite concerns of side effects from the new medication, the approval gives patients new hope after previous attempts to develop viable medicines have failed, NBC News reports.

The Approval Provides New Hope For Alzheimer's Patients

On Friday, the Food and Drug Administration authorized a treatment for Alzheimer's that had been demonstrated in clinical trials to halt cognitive loss in patients with the disease's early stages.

Lecanemab, a monoclonal antibody infusion that will be marketed under the name Leqembi, is a medication that is administered every two weeks.

Leqembi is the second drug in a newly approved class for Alzheimer's disease that addresses the illness's basic pathogenesis.

According to the Food and Drug Administration, these drugs are a significant step forward in the ongoing battle to properly treat Alzheimer's disease.

"This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease," Billy Dunn, M.D., director of the Office of Neuroscience says.

More than 6.5 million Americans suffer from Alzheimer's disease, an irreversible, progressive brain ailment that gradually impairs memory, reasoning, and, finally, the capacity to perform simple tasks.

Changes in the brain are a hallmark of Alzheimer's disease, despite the fact that its precise causes are not entirely understood.

This includes alterations to tau tangles and amyloid beta plaques, which cause neurons and their synapses to die, which impact a person's memory and thought processes.

Since the drug is not a cure, Leqembi has limited benefits, but anything that would allow patients to spend more time with their families and other loved ones is valuable, NBC News notes.

Researchers Have Evaluated The Efficacy Of Leqembi

The government expects to get the data soon after the findings of a Phase 3 randomized, controlled clinical trial to demonstrate the drug's clinical benefit were announced.

In a double-blind, placebo-controlled, parallel-group study with 856 Alzheimer's patients, researchers assessed Leqembi's effectiveness.

When amyloid beta pathology was confirmed in patients with mild cognitive impairment or mild dementia, treatment was started, the Food and Drug Administration writes.

These findings support Leqembi's expedited approval, which is justified by the reported decline in amyloid beta plaque levels, a sign of Alzheimer's disease.

However, it is important to note that Leqembi comes with a warning for amyloid-related imaging abnormalities (ARIA), which are known to happen when using antibodies from this class.

The most common symptom of ARIA is transient swelling in certain brain regions, which often goes away with time. It may also include small spots of bleeding inside the brain or on its surface.

Additionally, symptoms like headaches, confusion, dizziness, vision problems, nausea, and seizures can occur in some persons.

Leqembi is prescribed to treat Alzheimer's disease, as stated in the prescribing information, and on starting treatment at earlier or later stages of the disease than were evaluated, there are no safety or efficacy data.