The US FDA has extended its review of a supplemental application for Leqembi Iqlik (lecanemab-irmb), pushing the PDUFA date for the subcutaneous starting-dose formulation to August 24, 2026, as the agency works through additional information submitted by Eisai.
Eisai, in partnership with BioArctic AB (BIOA B, Nasdaq Stockholm), announced the FDA's three-month extension to the review of its supplemental Biologics License Application (sBLA) seeking approval of Leqembi Iqlik as a once-weekly subcutaneous starting dose for early Alzheimer's disease. The original PDUFA date was May 24, 2026. The agency made the change due to additional information requested of Eisai, deemed a major amendment to the sBLA and therefore requiring additional review time. Eisai said the FDA has not raised concerns regarding the approvability of the formulation.
The sBLA, which received Priority Review in January 2026, is specifically seeking approval for Leqembi Iqlik as an initiation therapy — distinct from the subcutaneous maintenance dosing regimen that the FDA approved on August 26, 2025. That earlier approval established Leqembi Iqlik for use via autoinjector following an initial intravenous treatment phase. The pending application, if approved, would allow patients to begin lecanemab therapy entirely via subcutaneous injection, removing the requirement for IV infusions during the induction period.
The extension reflects a procedural step rather than a signal of scientific concern, though the three-month delay does extend the period of uncertainty for a formulation that carries meaningful clinical implications. The shift from IV initiation to subcutaneous self-administration would substantially reduce the infrastructure burden currently associated with starting lecanemab therapy. Under the existing approval pathway, patients must access infusion centers for biweekly IV doses during the initial 18-month treatment phase before transitioning to subcutaneous maintenance dosing — a logistical constraint that has been cited as a barrier to broader uptake in community and rural settings.