NEW YORK – Eisai has filed a biologics license application (BLA) with the US Food and Drug Administration for a subcutaneous formulation of Leqembi (lecanemab), seeking approval for the beta-amyloid-targeting Alzheimer's disease drug as a maintenance treatment.
Eisai and its Leqembi marketing partner Biogen said Thursday that they completed filing the data for the BLA through a rolling submission. The FDA hasn't yet accepted the application, but once it does, a decision date under the Prescription Drug User Fee Act will be set.
Leqembi entered the US market in January 2023, when the FDA granted Eisai accelerated approval for an intravenous version of the drug. The regulator converted that accelerated approval to full approval in July 2023.
The FDA-approved label for Leqembi currently advises that patients receive biweekly intravenous infusions but doesn't specify at what point, if any, they can stop treatment. Now, in seeking approval for Leqembi as a maintenance treatment, Eisai is proposing that patients could receive a more convenient form of the drug after completing an initial regimen of biweekly infusions.
Tokyo-based Eisai earlier this year also submitted a supplemental BLA seeking approval for a lower dose of intravenous infusions of Leqembi taken monthly as a maintenance treatment, and the FDA expects to issue a decision on that application by Jan. 25, 2025. This new BLA is seeking approval for a weekly subcutaneous version of Leqembi that patients could administer at home with an autoinjector.
The BLA contains data from an open-label extension portion of the Phase III CLARITY AD trial and modeling of observational data. In support of maintenance dosing, Eisai has argued that even after clearance of beta-amyloid plaque, continued treatment with Leqembi will prolong benefits by targeting protofibrils, a toxic form of beta-amyloid. Not all neurologists are convinced by the argument.
Outside of the US, Leqembi is approved in Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. Eisai leads Leqembi's development and regulatory submissions globally, though Eisai and Cambridge, Massachusetts-based Biogen are commercializing and promoting the product together. Eisai has final decision-making authority.