Official announcement from the FDA

Eisai and Biogen Submit BLA for Fast Track Injectable Alzheimer’s Drug Leqembi via Autoinjector

May 15, 2024, 11:57 AM

Eisai and Biogen have initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a subcutaneous version of their Alzheimer's drug, Leqembi. This new formulation aims to provide patients with an injectable option via an autoinjector, transitioning from the current infusion method to weekly injections. The submission is under the Fast Track status, which is intended to expedite the review process for drugs that address unmet medical needs. The rolling application was previously delayed by the FDA on procedural grounds.