FDA Approves In-Home Use for Alzheimer's Treatment

The U.S. Food and Drug Administration has approved an at-home starting-dose option for the Alzheimer’s treatment Leqembi. The decision allows some patients to begin treatment with an under-the-skin injection administered by the patient or a caregiver.

Leqembi was developed by Eisai and Biogen for certain people diagnosed with early Alzheimer’s disease. The new authorization applies to the subcutaneous, or under-the-skin, form of the medication rather than the intravenous version traditionally administered at an infusion center.

An earlier FDA decision authorized a weekly injectable form of Leqembi for maintenance treatment after a patient completed an initial course of intravenous therapy. Monday’s action expands the at-home option by allowing eligible patients to begin treatment using injections.

The change could reduce some of the time and travel associated with repeated visits to an infusion facility. Patients will still require medical supervision, screening and monitoring because Leqembi can cause serious side effects, including swelling or bleeding in the brain.

Leqembi targets amyloid, a protein that can build up in the brains of people with Alzheimer’s disease. Clinical studies found that the treatment can slow cognitive decline in some patients, but it does not cure Alzheimer’s or restore abilities already lost to the disease.

Patients and caregivers should discuss eligibility, risks and administration instructions with a qualified healthcare professional. No one should begin, stop or change an Alzheimer’s treatment without guidance from the prescribing medical team.

(This story is AI Generated from information released by the FDA)