Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

Should the FDA approve the Leqembi Iqlik 500 mg subcutaneous (SC) dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The inje ...