| Published September 3, 2025

Eisai applies for FDA approval for Leqembi Iqlik as initial treatment

BioArctics Partner Eisai has begun a phased application process with the FDA for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector as a weekly initiation treatment for early Alzheimer's disease. The FDA has granted Fast Track status to the application, which follows the approval of Leqembi Iqlik for maintenance treatment. If approved, it will Leqembi Iqlik the first anti-amyloid treatment that allows for initial treatment at home.