Eisai and Biogen have announced that the U.S. Food and Drug Administration has approved a supplemental biologics licence application for a once weekly subcutaneous initiation dose of lecanemab irmb, branded as Leqembi Iqlik, for the treatment of early Alzheimer’s disease.
Leqembi Iqlik is delivered via an autoinjector, providing an alternative to intravenous dosing from the start of treatment.
The approved initiation regimen is 500 mg once weekly as two 250 mg injections, each administered in around 15 seconds. The therapy may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment.
Patients can receive Leqembi as either IV infusion or subcutaneous injection throughout the course of therapy and may switch between routes of administration.
Leqembi is indicated in the U.S. for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease. These earliest symptomatic stages can present with subtle signs such as forgetfulness, confusion or difficulty finding words.
The approval is supported by a clinical data set evaluating subcutaneous administration across multiple studies. Sub studies within the phase 3 Clarity AD long term extension showed that once weekly subcutaneous dosing achieved exposure equivalent to IV administration, supporting similar clinical and biomarker benefits.
Exposure‑related adverse events such as ARIA‑E are expected to be comparable with IV dosing, with no increase in isolated ARIA‑H compared to placebo. Injection‑related reactions were observed, mostly local, while systemic reactions were less frequent.
Howard Fillit, Co‑Founder and Chief Science Officer Emeritus of the Alzheimer’s Drug Discovery Foundation, said: “The approval of LEQEMBI IQLIK for initiation dosing marks a new era of Alzheimer’s treatments. For the first time, patients and their care partners have meaningful choice in how anti-amyloid treatment is delivered.”
He added: “As treatment approaches continue to expand, innovations in drug delivery will play a critical role in improving access to therapies, supporting the investigation of potential combination treatments, and advancing a precision medicine approach to Alzheimer’s care.”
The subcutaneous initiation dose offers the only at‑home administration option across the Alzheimer’s disease treatment pathway.
According to Eisai and Biogen, subcutaneous dosing may reduce clinic visit burden, reliance on infusion resources, preparation and monitoring time, and preserve infusion capacity for those who prefer or require IV therapy.
An autoinjector acceptability study found that 94% of patients and care partners reported the device was easy to use with high satisfaction and confidence.
