Chicago, July 13, 2026 — The Alzheimer’s Association welcomes today’s U.S. Food and Drug Administration (FDA) action to approve a subcutaneous starter dose of Leqembi® (lecanemab, Eisai/Biogen) for the treatment of early Alzheimer’s disease. With this approval, Leqembi IQLIK is the first anti-amyloid treatment that can be given subcutaneously throughout the full course of treatment.

People diagnosed with mild cognitive impairment (MCI) or early Alzheimer’s can now choose between starting Leqembi with weekly subcutaneous injections or with intravenous (IV) infusions every two weeks at a hospital or infusion center. Subcutaneous injections can be given at home or in a doctor’s office and take approximately 15 seconds.

“This action reflects the continued evolution of the Alzheimer’s treatment landscape,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “More options mean more people living with MCI and early Alzheimer’s — along with their care partners — can find the path that works best for them — and that is meaningful progress for families navigating this disease.”

In August 2025, the FDA approved weekly subcutaneous maintenance dosing of Leqembi, but only for people who had already completed 18 months of intravenous treatment. Today’s action goes further by allowing subcutaneous administration from day one. Leqembi is now the first Alzheimer’s drug approved for at-home use with an autoinjector — a small device already used for other conditions including diabetes, arthritis and severe allergies. For people who live far from an infusion center or face transportation, mobility or scheduling challenges, subcutaneous administration offers another way to receive treatment.

“This FDA action demonstrates the continued progress of anti-amyloid treatments for Alzheimer’s disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead. “We are seeing the field evolve in important ways — including improvements in drug delivery that make treatment more accessible and adaptable to people’s lives.”

In studies, the safety profile of subcutaneous Leqembi was similar to the intravenous form, with the most common side effects being mild to moderate reactions at the injection site.

As the field continues to make progress with early detection and treatment of Alzheimer’s and other diseases that cause dementia, the Alzheimer’s Association believes real-world data on long-term use of these treatments — alongside controlled clinical trials — helps clinicians, patients, researchers, drug developers, payers and regulators better understand the evolving landscape of treatment.

Participation in the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) by clinicians and patients is encouraged by the FDA in the Leqembi prescribing information. ALZ-NET is collecting clinical and safety data for patients treated with new FDA-approved Alzheimer’s disease therapies, and tracking the long-term health outcomes associated with their use in real-world settings. The evidence gathered will be used to advance research, improve health equity and patient care, and inform Alzheimer’s and other dementia treatment practices. For more information on ALZ-NET, or to inquire about participating, please visit alz-net.org.

The latest science on Alzheimer’s and other dementia is being shared at the Alzheimer’s Association International Conference® (AAIC®), July 12-15, 2026, in London and online. AAIC is the largest and most influential international meeting dedicated to advancing dementia science, convening thousands of researchers, clinicians and dementia professionals to share breakthroughs across treatment, diagnostics, risk reduction and care. This year’s program will feature the latest data on anti-amyloid therapies, blood-based biomarkers and emerging approaches to detection and prevention — reflecting the accelerating pace of progress in the field.