Eisai initiates rolling submission for Leqembi autoinjector BLA to FDA

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BioArctic AB’s partner Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector for weekly maintenance dosing. This follows the Fast Track designation granted by the FDA. In the U.S., Leqembi is indicated for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of the disease.

Leqembi Autoinjector Aims to Simplify Alzheimer’s Treatment

Stockholm, Sweden – BioArctic AB’s partner Eisai has announced the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb, marketed as Leqembi, as a subcutaneous autoinjector for weekly maintenance dosing. The FDA had previously granted Fast Track designation for this application. Leqembi is indicated in the U.S. for treating Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stages, collectively referred to as early AD.

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Currently, Leqembi is approved for biweekly intravenous (IV) treatment, typically administered at medical facilities. The new subcutaneous administration via an autoinjector simplifies home treatment, reducing the need for hospital visits and nursing care, thus making the treatment process more convenient for patients and their caregivers.

BioArctic's partner Eisai initiates FDA rolling submission for Leqembi subcutaneous autoinjector for Alzheimer's. A new treatment method for better patient convenience.

BioArctic’s partner Eisai initiates FDA rolling submission for Leqembi subcutaneous autoinjector for Alzheimer’s. A new treatment method for better patient convenience.

Advancing Alzheimer’s Treatment

Alzheimer’s disease is characterized by amyloid-beta (Aβ) plaque deposition, a hallmark of the disease. Data suggests that early and continued treatment can prolong benefits even after Aβ plaque is cleared from the brain. If approved, patients who have completed the biweekly IV initiation phase could transition to the subcutaneous autoinjector 360 mg weekly maintenance regimen, currently under FDA review. This method maintains effective drug concentrations to sustain the clearance of highly toxic protofibrils, which can continue causing neuronal injury even after Aβ plaque has been cleared.

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The BLA submission is based on data from the Phase 3 Clarity AD open-label extension (OLE) study and modeling of observed data.

Global Approvals and Submissions

Leqembi is already approved in the U.S., Japan, and China, with applications submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore, and Switzerland. In March 2024, Eisai also submitted a Supplemental Biologics License Application (sBLA) to the FDA for less frequent monthly IV maintenance dosing of Leqembi.

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Eisai leads Leqembi’s development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai holds final decision-making authority. BioArctic holds the rights to commercialize lecanemab in the Nordic region, pending European approval, and is preparing for joint commercialization with Eisai in the region.

The rolling submission of the BLA for Leqembi’s subcutaneous autoinjector marks a significant advancement in Alzheimer’s disease treatment. This new administration method promises to enhance patient convenience and adherence to treatment protocols, potentially improving outcomes for those in the early stages of Alzheimer’s disease.

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