FDA Approves Leqembi as Traditional Alzheimer’s Treatment

FDA Approves Leqembi: In an unprecedented move, the U.S. Food and Drug Administration (FDA) has granted traditional approval to Leqembi (lecanemab-irmb), a novel drug used to treat adult patients with Alzheimer’s Disease. This follows the successful completion of a confirmatory trial that established clinical benefits.

FDA Approves Leqembi as Traditional Alzheimer’s Disease Treatment

Leqembi, which has the distinction of being the first amyloid beta-directed antibody to transition from accelerated to traditional approval, is designed to decrease the formation of harmful amyloid plaques in the brain – a hallmark of Alzheimer’s Disease.

The FDA had initially greenlit Leqembi under its Accelerated Approval pathway in January, a process reserved for promising therapies addressing serious conditions with unmet medical needs. The drug’s potential was gauged based on its ability to reduce brain amyloid plaques, an indicator of Alzheimer’s progression. The recent clinical trial, a mandated part of the accelerated approval process, confirmed the drug’s effectiveness in patients.

Teresa Buracchio, the acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, hailed the drug’s validation as a major milestone. “Today’s action verifies that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” she announced.

Alzheimer’s Disease, a severe, progressive brain disorder that currently affects over 6.5 million Americans, gradually erodes memory and cognitive skills, eventually leading to an inability to perform simple tasks. Despite ongoing research, its specific causes remain elusive. However, the presence of amyloid beta plaques and neurofibrillary (tau) tangles in the brain, leading to neuron and connection loss, are known characteristics.

Leqembi’s efficacy was confirmed through Study 301, a comprehensive Phase 3 randomized, controlled clinical trial. It involved 1,795 Alzheimer’s patients across multiple centers and employed a double-blind, placebo-controlled, parallel-group design. The study observed statistically significant and clinically meaningful reductions in the decline of cognitive functions over an 18-month period compared to a placebo.

However, like any medication, Leqembi is not without side effects. The most common include headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), which may manifest as temporary brain swelling or bleeding. In rare cases, ARIA can result in life-threatening brain edema with associated seizures and other severe neurological symptoms. A boxed warning is included in the Leqembi’s prescribing information to highlight these potential risks.

The FDA cautions that patients who are homozygous for the ApoE ε4 allele are at a heightened risk of ARIA, underscoring the necessity for ApoE ε4 status testing prior to starting Leqembi. Additionally, patients taking anticoagulant medication have an increased risk of intracerebral hemorrhages while on Leqembi.

Eisai Inc., the pharmaceutical company behind Leqembi, has stated that the drug should be administered in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease, aligning with the conditions of their clinical trials.

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