Written By: Pharmacally Medical News Desk
- Eisai and Biogen have completed a rolling Supplemental Biologics License Application (sBLA) submission to the U.S. FDA for LEQEMBI IQLIK (lecanemab-irmb) under Fast Track status, seeking approval of a 500 mg weekly subcutaneous starting dose for early Alzheimer’s disease without prior intravenous (IV) dosing
- Eisai has also filed a New Drug Application (NDA) for the same LEQEMBI subcutaneous formulation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for early Alzheimer’s treatment initiation.
- The 500 mg dose corresponds to two 250 mg autoinjectors administered weekly, supported by Phase 3 Clarity AD open-label extension data showing comparable exposure and clinical benefits to the standard biweekly IV 10 mg/kg infusion.
- This application aims to enable patients to begin treatment at home with subcutaneous injections, offering a more convenient initial therapy option versus intravenous infusions, potentially reducing clinic visits and healthcare
- LEQEMBI IQLIK (lecanemab-irmb) was honored with the TIME Magazine Best Innovation Award in 2025, recognizing its innovative subcutaneous autoinjector formulation that enhances treatment accessibility for early Alzheimer’s patients.
Eisai in collaboration with Biogen has completed a rolling Supplemental Biologics License Application (sBLA) submission to the U.S. FDA and simultaneously submitted a New Drug Application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the subcutaneous formulation of LEQEMBI IQLIK (lecanemab-irmb). This subcutaneous autoinjector is designed as a weekly starting dose for the treatment of early Alzheimer’s disease (AD), including mild cognitive impairment and mild dementia stages.
Both submissions are supported by clinical data from Phase 3 Clarity AD open-label extension studies demonstrating that once-weekly 500 mg subcutaneous administration via two separate 250 mg autoinjectors achieves exposure levels, clinical benefits, and biomarker outcomes comparable to biweekly intravenous dosing. The safety profile was similar to intravenous administration, with systemic injection-related reactions occurring in less than 2% of patients.
If approved, this subcutaneous formulation will enable patients to initiate weekly treatment at home, offering an alternative to the current biweekly intravenous infusions that require hospital visits. Each autoinjector delivers the dose in approximately 15 seconds, potentially reducing the need for healthcare resources such as infusion preparation and nursing supervision. This treatment advancement aims to improve convenience and accessibility for patients and caregivers, streamlining the Alzheimer’s disease care pathway.
Alzheimer’s disease is a progressive neurodegenerative condition characterized by amyloid beta plaques and tau protein accumulation, with protofibrils playing a primary toxic role in neuronal damage and cognitive decline. LEQEMBI uniquely targets both protofibrils and amyloid plaques, potentially impacting downstream tau pathology. The drug is currently approved in over 50 countries and regions and under regulatory review in several others, underscoring its growing global presence in Alzheimer’s care.
The subcutaneous form’s safety monitoring includes vigilance for amyloid-related imaging abnormalities (ARIA), similar to the intravenous treatment, especially in ApoE ε4 homozygous patients who have increased ARIA risk. Baseline magnetic resonance imaging and ongoing observation are recommended during the initial weeks of therapy. Eisai leads the global development and regulatory submissions for LEQEMBI, with Biogen as co-Marketer.
This dual regulatory submission highlights Eisai’s commitment to providing innovative, patient-centered therapies that can be administered conveniently outside hospital settings, enhancing therapeutic access and potentially improving disease management outcomes worldwide.
To read detailed Phase 3 Clarity AD open-label extension trial click here.
References
Eisai Completes Rolling Submission to US FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status, Biogen 25 November 2025, https://investors.biogen.com/news-releases/news-release-details/eisai-completes-rolling-submission-us-fda-leqembir-iqliktm
Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan, Biogen, 27 November 2025, https://investors.biogen.com/news-releases/news-release-details/eisai-submits-new-drug-application-subcutaneous-formulation
Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan, Eisai, 28 November 2025, https://www.eisai.com/news/2025/news202582.html
Eisai Completes Rolling Submission to US FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status, Eisai, 26 November 2025, https://www.eisai.com/news/2025/news202581.html
Patient Gains a New Way to Continue Alzheimer’s Treatment as FDA Authorizes Eisai-Biogen’s ELEMBI IQLIK, Pharmacally, 30 August 2025, https://pharmacally.com/fda-approves-eisai-biogens-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-for-maintenance-dosing-in-early-alzheimers-disease/