FDA Approved Leqembi Subcutaneous Maintenance Dosing

LBC83

On August 30, 2025, Eisai (Japanese company leading the development of Leqembi) published a press release announcing FDA approval of Leqembi subcutaneous maintenance dosing. After the initial 18 months of treatment via infusions every two weeks, patients will have the option of continuing with infusions every four weeks or switching to a weekly subcutaneous shot of Leqembi.

Eisai is marketing this under the brand name Leqembi IQLIK (pronounced "IClick"). The autoinjector can be administered in approximately 15 seconds at home. 

The FDA approval was based on Leqembi subcutaneous sub-studies in the Phase 3 trial for Leqembi, where a range of subcutaneous doses were evaluated. These studies showed that after 18 months of initial IV dosing, the weekly subcutaneous dosing maintained clinical and biomarker benefits comparable to continued IV dosing.

"The safety of the Leqembi IQLIK autoinjector was studied in over 600 patients at a range of doses" as part of the Phase 3 trial. 49 patients received a weekly subcutaneous maintenance dose after at least 18 months of IV infusions every two weeks. None of these patients experienced any local or systemic injection-related adverse events.

"ARIA rates in patients who received a weekly … subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after18 months and are similar to the background rates of ARIA in patients without treatment."

The press release indicates that Leqembi IQLIK will be launched in the U.S. on October 6, 2025.

When I complete my 18 months of Leqembi infusions in December, I'm hoping to switch to the weekly IQLIK subcutaneous shots and be done with infusions.

https://www.eisai.com/news/2025/pdf/enews202559pdf.pdf

GEH

Oh my gosh... That is wonderful news!!! I am very patiently (not really) waiting for my first appointment (only ten more days😁) with a Neurologist at our local Barrows Neurological Institute. He will be only my second Neuro in three years. My first is/was not so good... I will add this bit of info to my gynormous list of questions etc I have ready. 😆 Thanks you so much for sharing!!

LBC83

As a follow-up, the Alzheimer's Association issued a Press Release about the FDA approval of the subcutaneous maintenance dosing for Leqembi. Maria C. Carrillo, PhD, Alzheimer's Association chief science officer and medical affairs lead, said "This FDA action demonstrates continued progress in the field of Alzheimer's treatment. We are seeing the evolution of amyloid targeting antibody treatments, including improvements in drug delivery and acknowledgement that this calss of treatments continues to demonstrate clinical benefit beyond the 18-month clinical trial data."

https://www.alz.org/news/2025/fda-action-approving-leqembi-subcutaneous-maintenance-dosing

allit

Thanks for posting. I knew this was coming but didn't know it was going to be this soon.