FDA Accepts application for Leqembi subcutaneous autoinjector for weekly maintenance dosing

LBC83

I'm a newbie to this group. I received my 15th infusion of Leqembi, and haven't had any issues.

I haven't seen any previous posts of this nature, but I thought those receiving Leqembi IV infusions might be interested in what the future holds …

Eisai (Japanese company that manufactures Leqembi) announced on January 14 that the FDA accepted their application for their Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, setting an action date for August 31, 2025 (this is the date when the FDA will hopefully announce their approval of Eisai's application).

In the press release, Eisai indicated the application was based on data from the Clarity AD study open-label extension and computer modeling of the observed data. If this application is accepted, Eisai notes that Leqembi will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector. They again noted the injection process is expected to take, on average, 15seconds. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly IV initiation phase ("exact period under discussion with the FDA"), would receive weekly doses that are expected to maintain the clinical and biomarker benefits.

The release then gives a good overview:

"AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque deposition. Only Leqembi works to fight AD in two ways: by continuously clearing protofibrils and rapidly clearing plaque. With continuous administration, Leqembi clears toxic protofibrils which can continue to cause neuronal injury even after amyloid-beta plaque has been cleared from the brain. Long-term three-year Leqembi data presented at the Alzheimer's Association International Conference2024 suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain."

I presume Eisai includes the part about clearing protofibrils to remind people that the other FDA-approved drug for amyloid plaque (Kisunla) exclusively works on the amyloid plaque and doesn't impact protofibrils.

The press release concludes with a summary of where Leqembi is approved: U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico, and Macau. Eisainotes that a committee in the European Medicines Agency recommended approval, and Eisai has submitted applications for approval of Leqembi in 17 countries and regions.

https://www.eisai.com/news/2025/news202502.html

South Dakota Dave

This is very good news!