FDA Greenlights LEQEMBI IQLIK for Subcutaneous Injection in Alzheimer's Care

FDA Approves LEQEMBI® IQLIK™ for Alzheimer's Disease

On August 29, 2025, the U.S. Food and Drug Administration (FDA) granted approval for the LEQEMBI® IQLIK™ (lecanemab-irmb) subcutaneous injection intended for maintenance dosing in early Alzheimer's disease (AD). Developed by Eisai Co., Ltd. and Biogen Inc., this innovative treatment signifies a breakthrough in the ongoing fight against dementia, particularly for patients diagnosed with mild cognitive impairment (MCI) or early dementia.

LEQEMBI IQLIK is distinctive as it allows for at-home administration, facilitating continuous treatment after the initial intravenous therapy period. Following completion of 18 months of intravenous treatment, patients can seamlessly transition to this new subcutaneous injection, which can be self-administered in roughly 15 seconds.

Clinical and Safety Insights

The approval is supported by significant clinical data derived from sub-studies within the Phase 3 Clarity AD open-label extension trial. These investigations found that initiating weekly administration of LEQEMBI IQLIK after the intravenous regimen successfully preserved the clinical and biomarker benefits that had been observed during the initial treatment phase. Importantly, safety assessments indicated that no patients experienced severe injection-related adverse events while using the LEQEMBI IQLIK autoinjector.

The safety profile was comparable to intravenous treatments, but with a noteworthy reduction in systemic reactions, which were less frequent with the subcutaneous option. While local reactions such as redness and swelling occurred in some patients, the overwhelming majority reported mild to moderate side effects that did not hinder further administration of the therapy.

Addressing Alzheimer's Effectively

Alzheimer's disease is characterized by the progressive accumulation of amyloid beta plaques and tau tangles, creating a neurotoxic environment that comprehensively impacts cognitive functions. LEQEMBI distinguishes itself by targeting not just the plaques, but also the protofibrils that are recognized as particularly harmful in the context of cognitive decline. Current research indicates that halting treatment can lead to a regression in biomarker levels and cognitive function—a compelling argument for the introduction of maintenance dosing. Based on findings from the Clarity AD study, the new subcutaneous treatment will enable patients to slow disease progression effectively.

Making Treatment Accessible

Eisai is dedicated to ensuring all suitable patients can access LEQEMBI IQLIK, offering vital support programs to aid patients and their families in navigating treatment and insurance processes. Additionally, the Patient Assistance Program will provide LEQEMBI at no cost to eligible patients—including those without adequate insurance coverage—further enabling access to this groundbreaking therapy.

Originally set for launch on October 6, 2025, LEQEMBI IQLIK is poised to transform how early Alzheimer's disease is managed, positioning itself as a pivotal player in enhancing patient care for those affected by this relentless condition. The approval not only diversifies treatment options available to patients but also empowers them to maintain their quality of life as they navigate the complexities of Alzheimer's disease.

Conclusion

With the availability of LEQEMBI IQLIK, a significant advancement in the treatment landscape for Alzheimer's disease has been achieved, promising patients greater autonomy in their care and the prospect of prolonged cognitive health.