# LEQEMBI IQLIK (lecanemab-irmb) subcutaneous initiation regimen PDUFA Event: Alzheimer's disease Canonical URL: https://biopharmsignal.com/pdufa-calendar/BIIB/leqembi-iqlik-subcutaneous-initiation-alzheimers-disease Ticker: BIIB Company: Biogen Event date: 2026-08-24 Event type: FDA Decision Stage: PDUFA Result: Approved Result date: 2026-07-13 Application type: sBLA Original PDUFA date superseded by early approval. FDA had extended the PDUFA action date from May 24 to August 24 after determining that additional informati... ## Event Timeline ### August 24, 2026 — Original PDUFA date superseded by early approval FDA had extended the PDUFA action date from May 24 to August 24 after determining that additional information submitted during review constituted a major amendment. The agency approved the sBLA on July 13, before the revised goal date. [Eisai — PDUFA review extension to August 24](https://stagemedia-us.eisai.com/2026-05-08-Update-on-FDA-Priority-Review-of-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-as-a-Starting-Dose-for-Early-Alzheimers-Disease) ### July 13, 2026 — FDA approved subcutaneous initiation dosing FDA approved LEQEMBI IQLIK as a once-weekly subcutaneous initiation regimen for early Alzheimer's disease. The approved 500 mg starting dose is administered as two 250 mg autoinjector injections. [Eisai — FDA approval of LEQEMBI IQLIK initiation dosing](https://media-us.eisai.com/2026-07-13-FDA-Approves-LEQEMBI-IQLIK-R-lecanemab-irmb-Subcutaneous-Injection-as-an-Initiation-Dose-for-Early-Alzheimers-Disease) ### May 8, 2026 — FDA extended the review by three months FDA requested additional information and treated the response as a major amendment, moving the PDUFA action date from May 24 to August 24, 2026. Eisai and Biogen said FDA had not raised approvability concerns at that time. [Biogen — FDA Priority Review extension](https://investors.biogen.com/node/30586/pdf) ### January 25, 2026 — FDA accepted the sBLA with Priority Review FDA accepted the sBLA for LEQEMBI IQLIK as a weekly subcutaneous starting dose and initially assigned a May 24, 2026 PDUFA action date. The application was supported by subcutaneous dosing data, including Phase 3 Clarity AD open-label extension substudies. [Eisai — sBLA acceptance and Priority Review](https://media-us.eisai.com/2026-01-25-FDA-Accepts-LEQEMBI-R-IQLIKTM-lecanemab-irmb-Supplemental-Biologics-License-Application-as-a-Subcutaneous-Starting-Dose-for-the-Treatment-of-Early-Alzheimers-Disease-under-Priority-Review) ### November 25, 2025 — Rolling sBLA submission completed Eisai completed the rolling sBLA seeking approval of a 500 mg once-weekly subcutaneous initiation regimen as an alternative to every-two-week intravenous initiation dosing. [Eisai — Rolling sBLA submission completed](https://stagemedia-us.eisai.com/2025-11-25-Eisai-Completes-Rolling-Submission-to-U-S-FDA-for-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Supplemental-Biologics-License-Application-as-a-Subcutaneous-Starting-Dose-for-the-Treatment-of-Early-Alzheimers-Disease-Under-Fast-Track-Status) ### September 3, 2025 — Rolling sBLA submission initiated Eisai initiated the rolling submission under Fast Track status. The application included data evaluating subcutaneous lecanemab across multiple doses and Clarity AD open-label extension substudies. [Eisai — Rolling sBLA submission initiated](https://www.eisai.com/news/2025/pdf/enews202560pdf.pdf) ### August 29, 2025 — FDA approved LEQEMBI IQLIK maintenance dosing FDA initially approved the once-weekly 360 mg subcutaneous autoinjector for maintenance dosing after 18 months of treatment, establishing the LEQEMBI IQLIK presentation later expanded to initiation therapy. [Biogen — FDA approval of LEQEMBI IQLIK maintenance dosing](https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous) ## Regulatory Designations - Priority Review FDA: [Eisai — FDA acceptance and Priority Review](https://media-us.eisai.com/2026-01-25-FDA-Accepts-LEQEMBI-R-IQLIKTM-lecanemab-irmb-Supplemental-Biologics-License-Application-as-a-Subcutaneous-Starting-Dose-for-the-Treatment-of-Early-Alzheimers-Disease-under-Priority-Review) - Fast Track FDA: [Eisai — Rolling sBLA initiated under Fast Track status](https://www.eisai.com/news/2025/pdf/enews202560pdf.pdf) ## Related Pages - BIIB PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/BIIB.md - BIIB company profile: https://biopharmsignal.com/company/BIIB.md - PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md ## Related News - 2026-09-03 — Stoke Therapeutics and Biogen Present Long-Term Clinical Data that Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC): https://biopharmsignal.com/news/BIIB/stoke-therapeutics-and-biogen-present-long-term-clinical-data-that-support-the-d-caea5702.md - 2026-09-03 — LEQEMBI® (lecanemab) Subcutaneous Formulation as an Initiation Treatment for Early Alzheimer’s Disease Approved in China: https://biopharmsignal.com/news/BIIB/leqembi-lecanemab-subcutaneous-formulation-as-an-initiation-treatment-for-early--ff189c91.md - 2026-09-01 — Stoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC): https://biopharmsignal.com/news/BIIB/stoke-therapeutics-and-biogen-announce-presentations-of-clinical-data-from-studi-cca8723b.md - 2026-08-31 — Canada’s Drug Agency Issues Final Positive Recommendation Supporting Public Reimbursement of LEQEMBI® (lecanemab) for Early Alzheimer’s Disease: https://biopharmsignal.com/news/BIIB/canada-s-drug-agency-issues-final-positive-recommendation-supporting-public-reim-4f2a358e.md - 2026-08-24 — LEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer’s Disease: https://biopharmsignal.com/news/BIIB/leqembi-iqlik-lecanemab-irmb-autoinjector-for-initiation-of-therapy-now-availabl-0c2e8c77.md