FDA Approves At-Home Injectable Leqembi for Alzheimer’s

The U.S. Food and Drug Administration (FDA) has approved Eisai’s at-home, subcutaneous autoinjector form of Leqembi® (lecanemab-irmb) for the treatment of early-stage Alzheimer’s disease. This approval marks the first time an Alzheimer’s therapy can be administered at home using an autoinjector, offering people living with Alzheimer’s and their caregivers a more convenient alternative to intravenous (IV) infusions.

Leqembi, an anti-amyloid therapy, was originally approved in July 2023 as a biweekly IV infusion for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. The newly approved formulation allows people who complete the initial IV infusion phase to transition to a weekly 360 mg subcutaneous injection at home, using a device that delivers the dose in approximately 15 seconds.

A Milestone in At-Home Care

The availability of an at-home injectable option is expected to ease the burden of treatment for people living with Alzheimer’s and their families, reducing the need for hospital or infusion center visits and nursing care. Eisai developed the subcutaneous formulation based on evidence from its Phase 3 CLARITY-AD trial and open-label extension, which showed sustained clinical and biomarker benefits when treatment continued beyond the initial plaque clearance phase.

“Today’s approval is an important step toward making Alzheimer’s treatments more accessible and manageable for the millions of people living with this disease,” said BrightFocus Foundation President and CEO Stacy Pagos Haller.

How Leqembi Works: Evidence From Clinical Trials

Leqembi targets toxic amyloid beta protofibrils in the brain, clearing these harmful clumps as well as the larger amyloid plaques that contribute to cognitive decline in Alzheimer’s disease.

The FDA’s decision was supported by results from the pivotal Phase 3 CLARITY-AD trial (NCT03887455), which demonstrated that Leqembi slowed clinical and functional decline by approximately 27% over 18 months compared to placebo in individuals with early Alzheimer’s disease. In addition, nearly half of the participants showed clearance of amyloid plaques on brain imaging after treatment.

The newly approved subcutaneous autoinjector formulation was further supported by data from an open-label extension of CLARITY-AD and modeling of observed data, which indicated that the weekly maintenance dosing effectively sustained drug levels and the clearance of amyloid protofibrils and plaques.

Long-term data also suggest that early and sustained treatment may prolong functional independence and cognitive benefits even after amyloid plaques have been cleared.

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.

People beginning Leqembi therapy will still complete a series of biweekly IV infusions before transitioning to the weekly at-home autoinjector. Eisai and the FDA are continuing to define the optimal duration of the IV initiation phase.

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).

Read Eisai’s full press release for more details.

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

Additional Resources About Leqembi

• Facts About Leqembi, a New Alzheimer’s Drug

• Video: The New Alzheimer’s Drug: What is Leqembi?

• Alzheimer’s Treatments