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Eisai Seeking FDA Approval of Subcutaneous Leqembi as Maintenance Therapy in Alzheimer's

NEW YORK – Eisai has initiated a rolling submission of a biologics license application (BLA) with the US Food and Drug Administration seeking approval for a subcutaneous formulation of its anti-amyloid Alzheimer's disease drug Leqembi (lecanemab-irmb) as a maintenance treatment, the firm said Tuesday.

The FDA last year approved Eisai and Biogen's Leqembi as a treatment for Alzheimer's patients with mild cognitive impairment or mild dementia. At the time, the monoclonal antibody, which targets and clears beta-amyloid plaque, was approved as an IV infusion. Tokyo-based Eisai and Cambridge, Massachusetts-based Biogen codeveloped the drug, but Eisai serves as the lead for development and regulatory submissions globally.

In its latest BLA, Eisai is seeking approval of a subcutaneous version of Leqembi, which company executives previously said will be more convenient and less burdensome than IV infusions and could be administered at home or in a medical facility. Patients would use a subcutaneous autoinjector for weekly maintenance dosing after completing an initial regimen of biweekly IV infusions.

With these weekly doses, the aim is to "maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils, which can continue to cause neuronal injury even after the amyloid-beta plaque has been cleared from the brain," Eisai and Biogen said in a statement, adding that since protofibrils are a particularly toxic form of amyloid-beta and thought to be a key driver of cognitive decline in Alzheimer's patients, reducing this biomarker may prevent disease progression.

Eisai was able to initiate the rolling BLA submission since Leqembi has fast-track status from the FDA. The company has submitted data on the subcutaneous formulation from the Phase III Clarity AD open-label extension study and modeling of observed data.

Separately, Eisai said it had submitted a supplemental BLA to the FDA in March seeking approval for a lower dose of the IV formulation of Leqembi as a maintenance treatment, which would be prescribed to patients on a monthly basis after initial beta-amyloid clearance to sustain removal of the biomarker.