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Latest From Eisai Co., Ltd.

Global First Approval For Daiichi’s EZH1/2 Inhibitor Valemetostat In Japan

Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.

Japan Approvals

Medicare Part B Premium Reduction In 2023 Has Reserves Built In If Lecanemab Launches

But premiums in future years made need to keep pace with accelerating Medicare spending on Alzheimer’s drugs.

Reimbursement Medicare

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
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