FDA approves Leqembi Iqlik subcutaneous injection as a starting dose for early Alzheimer’s disease
BioArctic’s partner Eisai has announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik) as a starting dose for the treatment of early Alzheimer’s disease.
“This approval represents another important step forward in the treatment of Alzheimer’s disease,” says Gunilla Osswald, CEO of BioArctic. “By providing a new administration option from the start of treatment, patients, caregivers and healthcare professionals gain greater flexibility in how therapy is delivered. As the Alzheimer’s treatment landscape continues to advance, innovations that simplify access and support individualized care will be increasingly important. We are encouraged to see Eisai’s diligent work to meet the diverse needs of people living with this difficult disease.”
The US launch is planned for late August 2026.
New clinical data on the Leqembi subcutaneous autoinjector presented
BioArctic’s partner Eisai has presented new data at the 2026 Alzheimer’s Association International Conference (AAIC), held in London, July 12-15, demonstrating that the Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration in people with early Alzheimer’s disease.
Leqembi Iqlik
Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance. It is administered via an autoinjector, offering a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as two 250 mg injections, each administered in approximately 15 seconds.
Leqembi Iqlik is already approved for maintenance dosing in the US at 360 mg once weekly, once 18 months of IV or subcutaneous treatment has been completed. Patients can now receive Leqembi either as an IV infusion or as a subcutaneous injection (SC) with Leqembi Iqlik throughout the entire treatment course – from initiation through maintenance and may switch between administration methods as needed, providing greater flexibility and convenience.
Leqembi is indicated in the US for the treatment of adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease, collectively referred to as early Alzheimer’s disease. MCI due to Alzheimer’s disease represents the earliest symptomatic stage of the disease and may be associated with subtle changes in memory, thinking, language, or daily functioning.
Published: July 14, 2026
