Leqembi At-Home Injectable Now FDA Approved for Starting Alzheimer’s Treatment

People prescribed the anti-amyloid treatment Leqembi for early-stage Alzheimer’s disease can now self-administer the drug at home starting from the beginning of treatment, following U.S. Food and Drug Administration (FDA) approval of this more convenient and accessible option. The at-home starting dose is expected to be available in the U.S. in August 2026.

Leqembi was initially developed as an IV infusion delivered in the clinic. In 2025, the FDA approved an at-home injectable formula for maintenance dosing (the phase of treatment that begins after the first 18 months). Now, people living with early-stage Alzheimer’s have the option to start and continue their treatment entirely through at-home injections. People taking Leqembi can also alternate between in-clinic infusions and at-home injections as needed or continue solely with infusions if that is their preference.

For people taking Leqembi and their caregivers, at-home injections from the start of treatment means potentially fewer trips to an infusion center, particularly in the early weeks of treatment when clinic visits can be the most burdensome. The ability to administer Leqembi entirely at home also broadens access to the drug to people for whom traveling to an infusion clinic is logistically or economically challenging if not impossible.

The FDA approval comes on the heels of evidence from the Phase 3 Clarity AD long-term extension (LTE) trial, which showed similar safety and efficacy results of at-home injections of Leqembi compared to IV administration. Read the full release from Leqembi’s manufacturer, Eisai.

How does Leqembi work?

Leqembi is an immunotherapy that targets amyloid-beta, a protein that can form toxic clumps called plaques that are one of the hallmarks of Alzheimer’s disease.

Clinical trial data showed that nearly half of those taking Leqembi showed clearance of brain plaques. Three years of newly reported “real-world” data showed that the vast majority of people taking Leqembi had no additional cognitive decline once they started treatment, while some even showed improvement.

Who is eligible?

Leqembi is approved for people diagnosed with mild cognitive impairment or early dementia due to Alzheimer’s disease. Individuals must also have evidence of amyloid plaques confirmed through a PET scan or spinal fluid test.

Cost and coverage

The total cost of Leqembi and individual out-of-pocket costs for treatment will vary depending on the length of treatment and insurance coverage. Physicians may consider stopping Leqembi treatment if amyloid PET imaging shows clearance of amyloid plaques to minimal levels. Eligible individuals on Medicare may receive coverage and reimbursement for Leqembi treatment.

Eisai offers free support services to help with understanding insurance, coverage options, and treatment logistics. For more information, visit www.leqembi.com or call 1-800-LEQEMBI (1-800-537-3624).

View a list of Alzheimer’s treatments and learn more about the innovative research funded by BrightFocus Foundation’s Alzheimer’s Disease Research program.