FDA accepts BLA for Leqembi subcutaneous autoinjector maintenance dosing

The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi for patients with mild cognitive impairment or mild dementia consistent with early-stage Alzheimer’s disease.

“The FDA’s acceptance of the Leqembi subcutaneous maintenance dosing [biologics license application] is important for patients in the early stages of Alzheimer’s disease because early and ongoing treatment has shown to slow the progression, helping patients maintain who they are for longer,” Tatsuyuki Yasuno, chairman and CEO of Eisai Inc., told Healio in an email.

According to a joint release from manufacturers Eisai and Biogen, the application was based on data from the CLARITY-AD (Study 301) openlabel extension and modeling of observed data.

Eisai and Biogen submitted the application in late 2024. Should the FDA grant full approval to lecanemab, it will become the only AD treatment that patients can administer subcutaneously at home using an autoinjector.

The FDA has set a Prescription Drug User Fee Act action date for August 31.

Editor's Note: This story was updated on Feb. 4 to clarify the FDA has accepted the biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi.