FDA Prioritizes Review of At-Home Injection for New Alzheimer's Patients

Silver Spring, Monday, 26 January 2026.
On January 25, 2026, regulators accelerated the timeline for a potential paradigm shift in Alzheimer’s care. The FDA granted Priority Review to Eisai and Biogen’s application for Leqembi Iqlik, a weekly subcutaneous autoinjector designed for newly diagnosed patients. With a decision expected by May 24, 2026, this approval would make Leqembi the sole anti-amyloid therapy offering fully at-home administration for both initiation and maintenance phases. This development is crucial for healthcare economics, as it promises to move patient volume away from infusion centers, significantly reducing the logistical burden on families and healthcare systems while potentially expanding access to early treatment.