As Eli Lilly’s plans for its Alzheimer’s medication donanemab get delayed, Eisai has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) in a bid to bring intravenous (IV) maintenance dosing of its drug Leqembi (lecanemab) to patients with early Alzheimer’s disease.

The sBLA is supported by the observed data that was modeled from the Phase II “Study 201” trial (NCT01767311), the Phase III Clarity AD study (NCT03887455), and the open-label extension studies associated with both respective trials.

As per the 31 March press announcement, patients who have completed the biweekly IV initiation phase are eligible to receive a monthly IV dose of Leqembi. The purpose of the monthly administration would be to “maintain effective drug concentration to sustain clearance of highly toxic protofibrils” which may cause further neuronal injury after amyloid beta plaque ablation.

In addition to the IV maintenance therapy, Eisai is looking to gain traction for its subcutaneous (SC) version as well. While the pharma giant had originally intended to submit a rolling Biologics License Application (BLA) for its weekly SC maintenance therapy in March 2024, the company shared that it was waylaid by various agency requirements. In compliance with the agency, Eisai has submitted a Fast Track designation request that will prompt FDA action within 60 days of submission.

Leqembi, a 100mg/ml IV injection indicated for the treatment of early Alzheimer’s, which is co-developed by Eisai and Biogen, gained FDA approval in July 2023. Eisai leads the drug’s global development and regulatory submissions while both Eisai and Biogen are responsible for the commercialisation of the product.

According to GlobalData’s consensus forecasts, Leqembi is expected to yield $7.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology.

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Biogen recently announced the decision cut ties with its drug Aduhelm (aducanumab), terminating its development and relinquishing the rights to the drug which has been a point of controversy for efficacy, reimbursement, and access.

Unlike Leqembi whose approval history has been relatively straightforward, Aduhelm was granted accelerated approval in 2021 despite an FDA advisory panel voting against approval. Moreover, the Centers for Medicare & Medicaid Services (CMS) said that it would provide coverage for the treatment only if it was being used in clinical trial settings. For Leqembi on the other hand, CMS okayed coverage upon its traditional approval provided physicians enter patient data into CMS mandated registries.