Posted by Michael Wonder on 08 May 2026
Update on FDA priority review of Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease
8 May 2026 - Eisai and Biogen today announced that the US FDA has extended the review period by three months for the supplemental biologics license application for a once weekly lecanemab-irmb subcutaneous injection (Leqembi Iqlik) as a starting dose for the treatment of early Alzheimer’s disease.
The new PDUFA action date is 24 August 2026.
