The U.S. Food and Drug Administration has approved an at-home starting dose of Eisai and Biogen’s Alzheimer’s drug Leqembi, allowing some patients to begin treatment with injections administered by themselves or a caregiver. The decision expands access to the drug’s subcutaneous formulation, which can now be used as a starter dose rather than only after patients begin therapy in a clinic.
Leqembi is already approved for adults with Alzheimer’s disease, a progressive brain disorder that affects memory, thinking and daily function. The drug targets amyloid beta, a protein that forms plaques in the brains of people with the disease, and its injectable version, Leqembi IQLIK, is designed to give patients a more convenient alternative to infusion-center visits.
Until now, patients starting treatment have received Leqembi through intravenous infusions, usually at a clinic, before later switching to maintenance treatment. With the new approval, the at-home option offers a simpler pathway for eligible patients and caregivers, while potentially reducing treatment burden on healthcare facilities.
The FDA said the injectable formulation can still cause reactions at the injection site, including redness, swelling, rash, pain, or bruising. Even so, the approval marks another step in making Alzheimer’s treatment more flexible and accessible for patients who may benefit from home-based administration.
