FDA Approves New Alzheimer’s Drug to Slow Cognitive Decline

FDA Approves New Alzheimer’s Drug to Slow Cognitive Decline

The U.S. Food and Drug Administration (FDA) on Friday approved a much-anticipated new drug designed to slow cognitive decline in patients with mild and early stages of Alzheimer’s disease.

FDA approval of the drug Leqembi, also known as lecanemab, comes just days after a congressional report slammed the regulator for giving the green light to another Alzheimer’s drug, Aduhelm.

And it was granted despite study results showing monoclonal antibody treatment carries the risk of brain swelling and bleeding.

Both drugs have been approved under an accelerated review process, which allows the FDA to expedite approval of drugs for serious conditions with unmet medical needs.

Leqembi and Aduhelm, jointly developed by Eisai of Japan and Biogen of the United States, “represent an important advance in the ongoing fight to find an effective treatment for Alzheimer’s disease,” the FDA said in a statement.

“Alzheimer’s disease immeasurably impacts the lives of those who suffer from it and has a devastating impact on their loved ones,” said Billy Dunn of the FDA’s Center for Drug Evaluation and Research in a statement.

Leqembi, Dunn said, is “the latest therapy that targets and affects the underlying disease process of Alzheimer’s, rather than just treating the symptoms of the disease.”

About 6.5 million Americans suffer from Alzheimer’s, which is characterized by memory loss and decreased mental functioning.

Preliminary data from a study of Leqembi, released in September, found it slowed cognitive decline by 27 percent in Alzheimer’s patients.

The phase 3 trial involved nearly 1,800 people divided between those receiving the drug and a placebo, and ran for 18 months.

The full study data, published in the New England Journal of Medicineexpressed concerns about the occurrence of “side effects”, including cerebral hemorrhage and swelling.

The results showed that 17.3 percent of patients given the drug experienced cerebral hemorrhage, compared with nine percent of those given a placebo.

And 12.6 percent of those taking the drug experienced brain swelling, compared with just 1.7 percent of those in the placebo group.

Deaths were reported at about the same rate in both arms of the study with the drug.

$26,500 per year

In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, collectively known as aggregates, which cause brain cell death and brain shrinkage.

Leqembi, given intravenously once every two weeks, works by targeting amyloid.

In the study, patients who received Leqembi had a statistically significant reduction in amyloid plaques in the brain compared to the placebo arm, which had no reduction in amyloid beta plaques.

Biogen and Eisai previously launched Aduhelm, but there was considerable controversy over whether it worked, and its 2021 approval resulted in three high-level FDA resignations.

A US Congressional inquiry said the accelerated approval process for Aduhelm, the first drug approved to treat Alzheimer’s in decades, was “riddled with irregularities,” criticizing both the agency and Biogen.

Cambridge, Massachusetts-based Biogen has set Aduhelm at an “unjustifiably high price” of $56,000 a year, the congressional record said.

Eisai said Leqembi will initially be priced at $26,500 a year and estimated that 100,000 Americans could get the drug in three years.

Joanne Pike, president and CEO of the Alzheimer’s Association, welcomed Leqembi’s approval but expressed concerns that its high cost could make it prohibitively expensive for most Americans, especially if it’s not covered by Medicare, the federal health insurance program for the elderly .

“People living with this deadly disease today do not have time to wait for a miracle drug or cure,” Pike said in a statement.

© Agence France-Presse

Leave a Comment