FDA Approves Injectable Leqembi for Early Alzheimer's Disease Treatment

The U.S. Food and Drug Administration (FDA) has granted approval for Leqembi Iqlik, a new subcutaneous formulation of the Alzheimer’s medication lecanemab, designed for weekly administration following an initial 18-month intravenous (IV) treatment phase. This innovative autoinjector allows patients with early Alzheimer's disease, specifically in the mild cognitive impairment or mild dementia stages, to receive treatment in about 15 seconds. After completing the IV phase, patients can opt to continue with monthly infusions or switch to the convenient weekly subcutaneous injections.

This development aims to make Alzheimer's management more accessible and less burdensome. Howard Fillit, M.D., cofounder and chief science officer at the Alzheimer's Drug Discovery Foundation, highlighted that transitioning to subcutaneous dosing is a crucial step toward simplifying treatment, akin to diabetes medications like GLP-1 analogs. He emphasized that this innovation could eventually allow patients to administer therapy at home, bypassing the need for infusions.

The approval is based on data from the phase 3 Clarity AD extension trial, which demonstrated that patients switching to weekly Leqembi Iqlik maintained clinical and biomarker improvements comparable to those continuing IV therapy. The safety profile of the subcutaneous formulation was similar to IV dosing, with systemic reactions occurring in less than 1% of patients compared to about 26% with infusions. Amyloid-related imaging abnormalities (ARIA) were comparable between the two methods and aligned with rates seen in untreated patients.

Eisai and Biogen are the manufacturers of Leqembi Iqlik. This advancement is expected to improve patient comfort and adherence to therapy, supporting future combination treatments and enhancing overall management of early Alzheimer’s disease.