The US Food and Drug Administration (FDA) has approved a supplemental biologics licence application for LEQEMBI IQLIK (lecanemab-irmb) as a once-weekly subcutaneous initiation treatment for adults with early Alzheimer’s disease. The decision makes LEQEMBI IQLIK the first anti-amyloid therapy approved for both initiation and maintenance dosing at home using an autoinjector in the United States.
LEQEMBI is indicated in the US for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with confirmed amyloid pathology before treatment. The newly approved initiation regimen consists of 500 mg once weekly, administered as two 250 mg subcutaneous injections, each delivered in approximately 15 seconds. Following 18 months of treatment, patients may continue with a 360 mg once-weekly maintenance dose administered subcutaneously or remain on intravenous therapy. Patients can also switch between intravenous and subcutaneous administration during treatment.
The approval is supported by a clinical data package that included sub-studies from the Phase 3 Clarity AD long-term extension trial. Weekly subcutaneous dosing achieved drug exposure comparable to intravenous infusion, supporting similar efficacy and amyloid plaque removal. The overall safety profile was generally consistent with intravenous administration, with exposure-related rates of amyloid-related imaging abnormalities with oedema (ARIA-E) expected to be comparable. Injection-site reactions occurred with subcutaneous dosing but were typically localised and mild.
Lecanemab carries a boxed warning for ARIA, including cerebral oedema and cerebral microhaemorrhages, which may be serious or, rarely, fatal. MRI monitoring before and during treatment remains recommended, and APOE ε4 homozygous patients are known to have an increased risk of ARIA. Appropriate patient selection and monitoring therefore remain essential when prescribing therapy.
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The companies say the availability of an at-home initiation option could reduce the burden of infusion appointments for patients and carers, decrease reliance on infusion services, shorten treatment administration times and preserve infusion capacity for patients who require or prefer intravenous therapy. In an autoinjector acceptability study, 94% of patients and care partners reported that the device was easy to use and expressed confidence administering treatment in the home setting.
LEQEMBI first received traditional FDA approval in 2023 after the Phase 3 Clarity AD trial demonstrated a 27% slowing of clinical decline over 18 months compared with placebo in patients with early Alzheimer’s disease. The latest approval expands the available route of administration rather than the approved patient population.
Eisai and Biogen plan to launch LEQEMBI IQLIK in the United States in late August 2026.
This news item has been summarised using AI and checked by humans before publication.
Sources
- Eisai news release
- Biogen investor news release
- US Food and Drug Administration
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