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Eisai and Biogen move to bring IV dosing for Leqembi to the US

2024-04-01

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Eisai’s Leqembi 100mg IV injection is approved to treat patients with early Alzheimer’s disease. Credits: joshimerbin/Shutterstock.com

Eisaii LLeqembiplans for its Alzheimer’s medication donanemab get delaearly Alzheimer’s diseasea 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.

TheEliLLillysupported by the observed data that was donanemabrom the Phase Eisaitudy 201” trial (NCT01767311), the Phase III Clarity AD study (NCT03887455), Food and Drug Administration (FDA)es associated with both respective trials.early Alzheimer’s disease

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 hadLeqembially 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 requirementsamyloid betance 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 Eisaihe 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.Eisai FDA

Leqembio:Eisai Biogen FDA Eisai Eisai Biogen

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

Forma Therapeuticsnounced the deciUSP30 inhibitor USP30cut 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.

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