Eisai and Biogen Submit sBLA to FDA for Monthly IV Maintenance Dosing of Leqembi in Early Alzheimer’s Disease

Apr 02, 2024 07:30 CST Updated 07:30

Eisai

Pharmaceutical Product R&D and Manufacturer

Biogen

New Drug Developer

▎WuXiEdited by Kant Content Team

Eisai and Biogen announced today that Eisai has submitted to the U.S. FDAMonthly maintenance treatment with Leqembi (lecanemab)The supplemental Biologics License Application (sBLA) is for the treatment of mild cognitive impairment or mild dementia stage of Alzheimer's disease (AD) in patients, collectively referred to as early AD.

As part of the maintenance treatment,Patients who have completed the initial treatment phase of Leqembi once every two weeks will receive maintenance treatment with Leqembi via intravenous infusion once a month to maintain effective drug concentration and continuously clear highly toxic fibrillar proteins.Fibrillin is considered to beβThe most toxic form of amyloid-beta (Aβ), these fibrillar proteins can continue to damage neurons even after Aβ plaques in the brain have been cleared. This sBLA is based on model analyses of clinical data from the Phase 2 clinical trial (Study 201) and its open-label extension study (OLE), as well as the Clarity AD study (Study 301) and its OLE study.

Eisai stated that it has submitted an application for the Fast Track designation for the subcutaneous injection formulation of Leqembi.Following the granting of Fast Track designation, a rolling submission of the sBLA will be initiated to seek approval for Leqembi subcutaneous injection as a maintenance therapy.

Image Source: 123RF

AD is a continuous neurotoxic process that begins before the deposition of Aβ plaques and continues after their appearance. Early treatment can slow the progression of AD, and continuing treatment after the clearance of Aβ plaques in the brain may extend the duration of patient benefit.The goal of maintenance therapy is to sustain clinical and biomarker benefits, and a once-monthly dosing regimen may be more convenient for some patients and their caregivers.

Leqembi is a monoclonal antibody targeting the Aβ protein, which has been approved for marketing by regulatory authorities in the United States, China, and Japan, and is currently under review by regulatory agencies in multiple countries and regions worldwide.

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References:

[1] Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA. Retrieved April 1, 2024, from https://www.prnewswire.com/news-releases/eisai-completes-submission-of-leqembi-lecanemab-irmb-supplemental-biologics-license-application-for-iv-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-to-the-us-fda-302104097.html

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