For Alzheimer’s Drug Leqembi, Coverage Hinges on Full FDA Approval

  • Jan 12, 2023

    Via the FDA’s accelerated approval pathway, Biogen and Eisai got the green light from federal regulators on Jan. 6 to take their Alzheimer’s drug Leqembi (lecanemab) to market. But sources tell AIS Health, a division of MMIT, that uptake and coverage of the medication will likely be underwhelming until it receives full FDA approval — a designation the manufacturers have already filed to acquire. 

    Leqembi represents the drugmakers’ second crack at offering a breakthrough Alzheimer’s drug, as they launched Aduhelm (aducanumab) in 2021 after it received its own accelerated approval nod despite considerable controversy over the medication’s safety and efficacy. Both drugs are monoclonal antibodies that aim to slow cognitive decline in Alzheimer’s patients by reducing amyloid plaque buildup on the brain of patients in early stages of the disease.  

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  • Leslie Small

    Leslie has been reporting and editing in various journalism roles for nearly a decade. Most recently, she was the senior editor of FierceHealthPayer, an e-newsletter covering the health insurance industry. A graduate of Penn State University, she previously served in editing roles at newspapers in Pennsylvania, Virginia and Colorado.

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