Subcutaneous Maintenance Dosing for Early Alzheimer’s Disease Now Under FDA Fast Track Status

Eisai Co., Ltd. and Biogen Inc. recently announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI® subcutaneous autoinjector for weekly maintenance dosing. 

According to the company's press release on May 14, 2024, the injection process requires less time than the intravenous (IV) formulation.

If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or medical facilities.

LEQEMBI (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody. It is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment or mild dementia stage of disease.

LEQEMBI is now approved in the U.S., Japan, and China, and applications have been 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.

Previously, Eisai submitted a Supplemental BLA for monthly LEQEMBI IV maintenance dosing to the FDA in March 2024.

According to the Alzheimer's Association's Alzheimer's Disease Facts and Figures, an estimated 6.5 million Americans aged 65 and older live with dementia due to AD.

As of May 16, 2024, the FDA has not approved a vaccine that prevents AD.