Leqembi Iqlik Receives Priority Review for Subcutaneous Treatment by FDA

FDA Grants Priority Review to Leqembi Iqlik for Subcutaneous Use

On January 25, 2026, BioArctic's partner, Eisai, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Leqembi Iqlik (lecanemab-irmb). This decision marks a significant step forward in the treatment options available for Alzheimer's disease, particularly for patients suffering from Mild Cognitive Impairment (MCI) or mild dementia, collectively known as early Alzheimer's disease.

Leqembi Iqlik stands out as it offers a subcutaneous (SC) autoinjector option for a weekly starting dose, a notable alternative to the existing bi-weekly intravenous (IV) administration method. If the FDA grants final approval, Leqembi Iqlik could revolutionize the treatment landscape by allowing patients to manage their treatment from home, significantly reducing the reliance on healthcare facilities.

The Significance of Subcutaneous Administration

The proposed 500 mg subcutaneous dosing regimen, involving two 250 mg injections, could simplify the complexities involved in current treatment protocols. Patients and their caregivers would have the flexibility to choose their preferred method of drug delivery, whether that be at home via SC administration or during medical visits with IV delivery for both initiation and maintenance therapy. Each injection takes about 15 seconds, making it a practical option for those requiring treatment.

In comparison to the existing IV approach, which necessitates infusion preparations and nursing oversight, the SC method is expected to optimize healthcare resources and make treatment pathways more efficient. Findings from recent trials have shown that while the dosing schedule varies, the levels of effective exposure and clinical outcomes remained consistent between SC and IV methods.

Robust Clinical Data Support

The sBLA submission is supported by extensive data evaluated from multiple doses of lecanemab within the Phase 3 Clarity Alzheimer's disease open-label extension study, following an 18-month core investigation phase. The data indicated that subcutaneous administration was not only feasible but also maintained a safety profile similar to that observed in IV administration, with adverse reactions reported at under 2%.

Leqembi is distinguished as a dual-action treatment, targeting both protofibrils and amyloid plaques, the primary pathological features associated with Alzheimer's disease. This unique mechanism of action emphasizes its potential as a treatment option that addresses the underlying processes contributing to disease progression.

Upcoming FDA Action Date

The FDA has earmarked May 24, 2026, as the Prescription Drug User Fee Act (PDUFA) action date for a final review of the sBLA. Should the agency grant approval, Leqembi Iqlik will be the first anti-amyloid treatment to offer the convenience of at-home injections all through the treatment journey from initiation to maintenance, an aspect sorely needed for those battling this relentless disease.

BioArctic and Eisai Collaboration

Since 2005, BioArctic and Eisai have maintained a long-standing partnership focusing on innovative Alzheimer's disease treatments. Together, they have developed Leqembi, a humanized monoclonal antibody that holds the potential to alter the course of Alzheimer’s disease for many patients. Leqembi is currently approved in 53 countries worldwide and under review in several others, reflecting its global significance in the fight against Alzheimer's disease.

As the world awaits the FDA's final decision, this announcement not only highlights the latest advancements in Alzheimer's research but also brings hope to countless individuals and families affected by this debilitating condition. Stay tuned for updates on Leqembi Iqlik and its potential approval for subcutaneous administration in treating early Alzheimer's disease.