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Latest From Eisai Co., Ltd.

Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances?

Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.

Reimbursement Medicare

Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever

Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.

Drug Approval Standards Drug Review

Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Clinical Trials Neurology

A Banner Moment For Alzheimer's Positions Eisai/Biogen At The Head Of The Pack

Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.

Clinical Trials Strategy
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Company Information

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  • Other Names / Subsidiaries
    • EA Pharma Co., Ltd.
    • Eisai China Inc
    • Eisai Laboratorios
    • Eisai Mexico
    • Eisai Participacoes Ltda. (Brazil Subsidiary)
    • H3 Biomedicine
    • HI-Eisai Pharmaceutical Inc.
    • Jingyi Weixiang (Shanghai) Health Industry Development Limited
    • Liaoning TianYi Biological Pharmaceutical Co., Ltd.
    • KAN Research Institute, Inc.
    • MGI Pharma, Inc.
    • Morphotek, Inc.
    • Zycos Inc.
    • Eisai Vietnam Co., Ltd.
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