LEQEMBI IQLIK (lecanemab SC) PDUFA Date (Eisai / Biogen)
FDA PDUFA decision date for LEQEMBI IQLIK (lecanemab SC) is May 24, 2026. Developed by Eisai / Biogen. Indication: Early Alzheimer's disease (subcutaneous autoinjector). Current status: Approved.
Indication
Early Alzheimer's disease (subcutaneous autoinjector)
Notes
SC formulation of already-approved Leqembi. High probability — formulation change, not new molecule.
Regulatory details
- Company: Eisai / Biogen
- Therapeutic area: Neurology / CNS
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-05-24
- Outcome: Approved