FDA Approves LEQEMBI® Application for Early Alzheimer's Subcutaneous Dosing

In a significant development, Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous form of their Alzheimer's treatment, LEQEMBI (lecanemab-irmb). This therapy, designed for patients with early stages of Alzheimer's disease, offers a weekly maintenance dose that can be administered at home. The FDA has set a decision date for this application on August 31, 2025.

LEQEMBI, already available in various countries, is pioneering in the realm of anti-amyloid therapies as it potentially offers the convenience of at-home treatment through a subcutaneous autoinjector. This mode of application could alleviate the need for hospital visits, providing an easier treatment option for patients and caregivers. The average injection time is estimated to be around 15 seconds.

Alzheimer's disease (AD) is characterized by the accumulation of amyloid-beta plaques in the brain, leading to neurodegeneration. LEQEMBI distinguishes itself by actively removing protofibrils, which are toxic precursors to these plaques, and by rapidly eliminating existing plaques. This dual-action mechanism could offer sustained clinical benefits, even after the visible plaques have been cleared.

The acceptance of the BLA by the FDA was based on data from ongoing studies, including the Clarity AD open-label extension. This research underlines that continuous treatment with LEQEMBI may extend its therapeutic benefits, as evidenced by data presented at the 2024 Alzheimer's Association International Conference. If approved, this treatment would provide the first subcutaneous option for Alzheimer's patients, simplifying the treatment pathway significantly.

LEQEMBI has already secured approval in multiple countries, including the U.S., Japan, China, and several others. The treatment has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as of November 2024. Eisai is leading the regulatory submission efforts globally, with Biogen as a co-commercial partner.

The strategy behind LEQEMBI's development involves a collaboration between Eisai and BioArctic. Initially licensed in 2007, Eisai holds the global rights for its development and marketing. The research and development efforts have been supported by data from extensive clinical trials, demonstrating the drug's efficacy in slowing the progression of Alzheimer's disease.

Furthermore, Eisai and Biogen's partnership extends beyond the commercialization of LEQEMBI, as both companies continue to explore treatments for Alzheimer's and related neurological conditions. Their collaborative efforts aim to address the unmet medical needs in treating this debilitating condition, leveraging their combined expertise in biotechnology and pharmaceuticals.

Should the FDA approve LEQEMBI's subcutaneous form, it would mark a milestone in Alzheimer's treatment, promising a more patient-friendly approach that could improve adherence and outcomes for those suffering from the early stages of this chronic disease. As Eisai and Biogen await the FDA's decision, the potential impact of LEQEMBI's innovative delivery method remains a focal point in the ongoing battle against Alzheimer's disease.