FDA Approves Eisai And Biogen's Leqembi For Alzheimer's Disease Treatment

(RTTNews) - The U.S. Food and Drug Administration approved Eisai Co., Ltd. and Biogen Inc.'s (BIIB) Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer's disease.

The approval is based on Phase 2 data that demonstrated that Leqembi reduced the accumulation of Aß plaque in the brain, a defining feature of Alzheimer's disease. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity Alzheimer's disease, Eisai will work quickly to file a Supplemental Biologics License Application to the FDA for approval under the traditional pathway.

Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer's are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connection.

The recommended dosage of Leqembi is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of Aß pathology prior to initiating treatment. Enhanced clinical vigilance for amyloid-related imaging abnormalities (ARIA) is recommended during the first 14 weeks of treatment with Leqembi.

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