The U.S. Food and Drug Administration (FDA) has approved an at-home starter dose for Leqembi (lecanemab), the Alzheimer’s disease therapy jointly developed by Eisai and Biogen, marking a significant step toward improving treatment convenience for patients with early Alzheimer’s disease.

Until now, patients initiating Leqembi therapy were required to receive intravenous (IV) infusions at hospitals or infusion centres, before transitioning to maintenance treatment after approximately 18 months. The latest FDA approval allows eligible patients to begin treatment at home, reducing the need for frequent hospital visits and improving access to therapy.

Leqembi is the first anti amyloid therapy shown to slow cognitive decline in patients with early Alzheimer’s disease by targeting and clearing amyloid beta plaques, a hallmark of the disease. The approval is expected to ease the treatment burden on patients, caregivers and healthcare systems while supporting wider adoption of disease modifying therapies.

According to the World Health Organization (WHO), more than 55 million people worldwide are living with dementia, with Alzheimer’s disease accounting for 60–70% of all cases. The number is projected to rise sharply as populations age, increasing the demand for innovative therapies that can delay disease progression.

Healthcare experts welcomed the FDA’s decision, stating that home based treatment options can improve patient adherence, reduce travel and infusion related challenges, and enhance quality of life for individuals with early stage Alzheimer’s disease. However, they noted that patients receiving Leqembi will continue to require regular clinical monitoring for potential side effects, including Amyloid Related Imaging Abnormalities (ARIA), a known risk associated with anti amyloid therapies.

The approval reflects the growing shift toward patient centric neurological care, combining innovative treatments with more accessible delivery models to improve outcomes for people living with Alzheimer’s disease.