FDA fully approves ‘novel’ Alzheimer’s disease drug Leqembi, will be covered by Medicare

The Food and Drug Administration (FDA) has fully approved a “novel” drug used to treat adult patients with Alzheimer’s, the agency announced.

Leqembi, which is produced by Japanese drugmaker Eisai and American-based drugmaker Biogen, was initially approved in January under the Accelerated Approval pathway. After promising clinical trials, the drug was given traditional approval Thursday.

“Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease,” the FDA explained in a press release.

“The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease,” the statement added.

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Medicare administrator Chiquita Brooks-LaSure announced that the program will begin covering the drug, but Medicare patients will also be required to enroll in a registry to track its effectiveness.

“[Medicare] will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said in a statement obtained by the Associated Press.

Clinical trials showed that the drug can slow the progression of Alzheimer’s disease by 27% for early-stage patients.

Alzheimer’s is a progressive, irreversible brain disorder that can destroy a patient’s memory and cognitive skills. The cause of the disease, which 6.5 million Americans have, is unknown.

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“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. 

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

The FDA disclosed that patients who take anticoagulant medication, or blood thinners, are at increased risk of hemorrhages with Leqembi. Leqembi is also only approved for use by Alzheimer’s patients in the mild dementia or cognitive impairment stage of the disease. 

“The labeling states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied,” the FDA added.