The U.S. Food and Drug Administration (FDA) has approved Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing.
Leqembi is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. (early Alzheimer’s disease).
After 18 Months, Take It Once-a-Month Instead of Every 2 Weeks
This approval means that patients who have completed the biweekly initiation phase of 18 months have the option to transition to a once every four weeks 10 mg/kg dosing regimen.
Eisai has previously published data supporting the importance of continued ongoing treatment.
Amyloid Reaccumulates When Leqembi is Stopped
Data from the off-treatment period between the Phase 2 core study and its long-term extension (LTE) showed that discontinuation of treatment is associated with reaccumulation of brain amyloid, and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline.[1]
Meaningful Benefit in Early Alzheimer’s
In addition, recent data of three years of bi-weekly treatment across the Phase 3 Clarity AD core study and LTE, showed that Leqembi reduced cognitive decline on the CDR-SB by -0.95 relative to a matched natural history cohort – more than double the mean change from baseline relative to placebo on the CDR-SB at 18 months (-0.45) – showing expanded clinical and personally meaningful benefit for early AD patients.[2]
Leqembi Clears the Brain in Two Ways
Alzheimer’s disease is caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Continuous administration of Leqembi is of great value to patients as Leqembi works to fight Alzheimer’s Disease in two ways: not only rapidly clearing the amyloid-beta (Aβ) plaque, but it also works to fight the progressive nature of Alzheimer’s disease by continuously clearing the highly toxic protofibrils that otherwise continue to cause neuronal injury.
The sBLA for the once every 4-week dosing regimen is based on modeling of observed data from the Phase 2 study and its long-term extension (LTE) as well as the Clarity AD study and its LTE study. Modeling simulations predict that transitioning to once every 4 weeks maintenance dosing after 18 months of biweekly treatment will maintain clinical and biomarker benefits of therapy.
Leqembi is already approved in:
- the US,
- Japan,
- China,
- Great Britain,
- Israel,
- United Arab Emirates
- South Korea and
- Several other markets.
Europe
In November 2024, a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of lecanemab (generic Leqembi®).1 As part of its decision-making process, the European Commission (EC) has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.
The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified. We believe that the EC’s requests can be addressed with existing information and will be evaluated by the CHMP because of the clear and sufficient information available. We will continue to work closely with the authorities toward approval in the EU.
We will continue to make every effort to deliver lecanemab to patients with early AD in EU countries as soon as possible.
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Autoinjector
Furthermore, the FDA accepted Eisai’s Supplemental Biologics License (BLA) for the Leqembi subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.