FDA Accepts Biologics License Application for Lecanemab-irmb

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The US Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.¹ Lecanemab is indicated for the treatment of Alzheimer disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.

If lecanemab-irmb subcutaneous maintenance dosing is approved by the FDA, it will be the only treatment for Alzheimer disease that can be administered subcutaneously at home using an autoinjector. The injection process takes approximately 15 seconds. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly IV initiation phase would receive weekly doses that would maintain clinical and biomarker benefits.

The SC-AI is designed to be simple and easy for patients and caregivers to use. It may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and simplify care.

The BLA is based on data from the phase 3 Clarity study open-label extension and modeling of observed data. This study was a large-scale trial that included 1795 participants who had evidence of amyloid on positron emission tomography and/or lumbar puncture for cerebrospinal fluid, who were followed around for an 18-month treatment period. Following lecanemab’s approval in July 2023, investigators conducted a follow-up analysis of the trial, focused on the effects of patients who were treated with subcutaneous lecanemab compared with those on biweekly IV lecanemab. The analysis showed that after 6 months of treatment, participants on the SC-AI demonstrated a 14% increased amyloid plaque removal compared with those who received IV administration.²

Eisai and Biogen initiated a rolling submission for lecanemab-irmb weekly maintenance dosing back in May of 2024.³ The FDA’s fast-track designation for the approved IV Leqembi did not extend to the new SC-AI formulation. Another setback: the rolling submission, originally scheduled for March 2024, was delayed after the FDA requested additional 3-month immunogenicity data on the SC formulation proposed maintenance dose of 360 mg weekly.⁴ Now, a Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025.

Lecanemab is currently approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico, and Macau. Eisai has submitted applications for approval of lecanemab in 17 total countries and regions. The FDA has already accepted Eisai's Supplemental Biologics License Application for monthly Leqembi IV maintenance dosing as of June 2024 and set a PDUFA action date for January 25, 2025.

References

1. FDA accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for subcutaneous maintenance dosing for the treatment of early Alzheimer's disease. News release. January 13, 2025. Accessed January 14, 2025. https://www.prnewswire.com/news-releases/fda-accepts-leqembi-lecanemab-irmb-biologics-license-application-for-subcutaneous-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-302349842.html

2. Irizarry M, Li D, Dhadda S, et al. Preliminary update on lecanemab safety in Clarity AD open-label extension, including subcutaneous formulation. Presented at: CTAD conference; October 24-27, 2023; Presentation 4.

3. Kuntz L. Rolling submission for subcutaneous lecanemab. Psychiatric Times. May 15, 2024. https://www.psychiatrictimes.com/view/rolling-submission-for-subcutaneous-lecanemab

4. O’Brien E. FDA: specific fast track designation for subcutaneous formulation of Leqembi for Alzheimer disease needed for rolling review. Psychiatric Times. April 3, 2024. https://www.psychiatrictimes.com/view/fda-specific-fast-track-designation-for-subcutaneous-formulation-of-leqembi-for-alzheimer-disease-needed-for-rolling-review