#USA #Stockholm #Eisai #Leqembi #Alzheimer's Disease

Leqembi® IQKLIK™ Approval by US FDA

In a significant advancement in the fight against Alzheimer's disease, the United States Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Leqembi® IQKLIK™ (lecanemab-irmb), a subcutaneous injection designed for maintenance dosing. This newly approved formulation aims to treat patients suffering from early-stage Alzheimer's disease, specifically those experiencing mild cognitive impairment (MCI) or mild dementia. The FDA's approval was announced by Eisai Co., Ltd, a partner company of BioArctic AB, on August 29, 2025.

What is Leqembi® IQKLIK™?

Leqembi® IQKLIK™ is a once-weekly injection that represents a noteworthy development in Alzheimer’s disease management. After an initial 18 months of intravenous treatment at a dose of 10 mg/kg, patients can transition either to continued intravenous infusions or switch to the new weekly subcutaneous injection of 360 mg using the Leqembi IQKLIK autoinjector.

Alzheimer's disease, characterized by the progressive decline in cognitive functions, has long presented challenges for patients and caregivers alike. As the disease progresses, it presents multiple stages, each requiring different levels of care and support. Leqembi is the only treatment targeting both amyloid plaque and protofibrils, two key factors associated with Alzheimer's pathology, thus offering hope in lowering the disease's progression and maintaining a better quality of life for patients longer.

The Need for Effective Treatment Options

The significance of new treatment options like Leqembi cannot be overstated given the persistent unmet needs in managing Alzheimer’s disease. Current treatments often fail to address the disease’s progression effectively. With Leqembi, the dual-action design targets the underlying pathology, which may ultimately reduce the cognitive decline that burdens patients.

Gunilla Osswald, the CEO of BioArctic, emphasized that Eisai's ongoing efforts to simplify patient treatment procedures are crucial in alleviating healthcare burdens while extending accessibility for patients. As a patient-administered device, the autoinjector can be used at home, which shortens treatment times and reduces the requirement for hospital visits for infusions. This change is expected to improve not only patient experience but also streamline resource utilization in healthcare settings, leading to a more efficient treatment pathway for Alzheimer's disease.

Implications for Future Research and Care

The development of Leqembi is rooted in a longstanding collaboration between BioArctic and Eisai, with research initially spearheaded by Professor Lars Lannfelt. To date, lecanemab has gained approval in 48 countries and is still undergoing regulatory review in ten other markets. Ongoing clinical studies underscore the commitment to understanding lecanemab's efficacy in various patient populations, including those not yet exhibiting obvious clinical symptoms of Alzheimer's yet show signs of amyloid accumulation in their brains.

On a broader scale, the ongoing Phases 3 clinical studies, along with multiple public-private partnerships, indicate the robust framework supporting Alzheimer's research and development. In particular, initiatives like the AHEAD study and the Tau NexGen study offer promising avenues toward understanding Alzheimer’s further and finding effective interventions.

Conclusion

As Leqembi® IQKLIK™ prepares for its October 2025 launch, there is renewed optimism in the fight against Alzheimer’s, a disease that has historically been challenging to manage. By not only addressing symptoms but also targeting core biological processes involved in cognitive decline, this new treatment option sets a promising precedent for the future of Alzheimer’s care. This innovation may ultimately help patients hold on to their identity longer, providing them, their families, and caregivers a better quality of life amid the challenges of this devastating condition.