LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector - weekly initiation dose
FDA PDUFA Target Action Date · Biogen Inc.
Note: Approved 2026-07-13 (42 days early) as LEQEMBI IQLIK sBLA (SUPPL-1, EFFICACY, BLA761375 in drugs.json): once-weekly subcutaneous initiation dose for early Alzheimer disease. BLA held by Eisai (Biogen is the 50/50 partner). Source: Eisai press release 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
Drug Information
- Drug Name
- LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector - weekly initiation dose (CT.gov)
- Application Type
- sBLA
- Indication
- Early Alzheimer's disease (subcutaneous autoinjector initiation dosing)
- Approved As
- LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector - weekly initiation dose
Filing Details
- Company
- Biogen Inc. →
- Stock Ticker
- BIIB
- Source
- SEC 10-Q →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Biogen Inc.
View Biogen Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue