I think this is unfair and I would like to know if anyone else has faced this issue of being refused treatment because of anosognosia and what they have done about it.

thank you, rgm3

The press release notes that Eisa's application to the FDA for maintenance dosing was based on analytical modeling of observed data from the Phase 2 study with Leqembi and the long-term extension as well as the Phase 3 study and its long-term extension. "Modeling simulations prediction that transitioning to once every 4 weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy."

The press release repeats the Eisai standard mantra about Leqembi & AD: "AD is a progressive, relentless disease caused by a continuous underlying neuro toxicprocess that begins before and continues after plaque removal. Only Leqembi works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque [side note: Kisunla doesn't clear protofibrils]. This is important because with continuous administration, Leqembi clears highly toxic protofibrils which can continue to cause neural injury even after the amyloid-beta plaque has been cleared from the brain."

The press release goes on to explain the importance of ongoing treatment:

Data from a previous off-treatment period in the Phase 2 core study and the long-term extension showed that a discontinuation of treatment resulted in the reaccumulation of amyloid PET and plasma CSF biomarkers, and reversion to the placebo rate of clinical decline.

For maintenance treatment, once every 4 weeks dosing regimen may be easier than once every 2weeks dosing for patients and care partners to continue treatment for early AD

Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.

Over 3 years of treatment in the Phase 3 clinical trial and the long-term extension, Leqembi reduced cognitive decline on the Clinical Dementia Rating - Sum of Boxes(CDR-SB) by -0.95 relative to a matched natural history cohort - showing clinically meaningful benefit for early AD patients. The press release notes that "A change from 0.5 to 1 on the CDR-SB score domains of Memory, Community Affairs and Home/Hobbies is the difference between slight impairment and loss of independence, such as people's ability to be left alone, remember recent events, participate in daily activities, complete household chores, function independently and engage in hobbies and intellectual interests."

https://www.eisai.com/news/2025/news202506.html

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