Aducanumab-avwa

Eisai’s Leqembi 100mg IV injection is approved to treat patients with early Alzheimer’s disease. Credits: joshimerbin/Shutterstock.com 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. See Also: Novartis gets grant for treatment of cocaine use disorder using mavoglurant Forma Therapeutics gets grant for USP30 inhibitor compounds for medical use According to GlobalData’s consensus forecasts, Leqembi is expected to yield $7.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology . 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.

Pictured: Magnetic resonance imaging scans of the brain/iStock, Nur Ceren Demir Biogen and Eisai on Monday announced that they have missed their March 2024 target of filling a Biologics License Application for a subcutaneous formulation of their Alzheimer’s disease therapy Leqembi (lecanemab), being proposed as a weekly maintenance regimen. The companies initially planned to start a rolling Biologics License Application (BLA) last month under the existing Fast Track and Breakthrough Therapy designations for Leqembi. However, the regulator informed Eisai that they would need a Fast Track designation specifically for the subcutaneous formulation before they can launch their rolling application, according to Monday’s announcement. Eisai has since submitted a request for the Fast Track designation and is set to receive a verdict within 60 days of its filing. If granted, the partners will launch their rolling BLA. The companies also announced that they have filed a supplemental BLA (sBLA) proposing a monthly intravenous maintenance dosing schedule for Leqembi. If approved, this maintenance regimen will be available for patients who complete the biweekly intravenous initiation phase, though the exact duration for this is still under discussion with the FDA. Currently, Leqembi is approved as an intravenous infusion given over approximately one hour, every two weeks, according to its label. Leqembi’s monthly infusion schedule is designed to sustain effective drug levels in the body, enough to keep the toxic protofibrils at bay. In patients with Alzheimer’s disease, these protofibrils can still trigger neuronal damage and brain injury even amyloid-beta plaques have been removed, according to the companies. Biogen and Leqembi are supporting the sBLA with modelling data from results of the Phase IIb Study 201 and its open-label extension phase, as well as the Phase III Clarity AD study and its open-label extension. Leqembi is a humanized IgG1 monoclonal antibody that works by targeting aggregated soluble and insoluble amyloid-beta plaques. This mode of action helps clear these clumps from the brain, which would otherwise interfere with cognition and give rise to the hallmark symptoms of Alzheimer’s disease. Based on data from Study 201, which showed that Leqembi could decrease the levels of amyloid-beta plaques in the brain, the FDA granted Leqembi accelerated approval in January 2023. In July 2023, the regulator converted its nod into a full approval, making Leqembi the first anti-amyloid antibody to earn this distinction. Leqembi’s traditional approval was based on the Clarity AD, which demonstrated that the biomarker effects observed in Study 201 translated to clinical benefits. Patients treated with Leqembi saw a 27% reduction in clinical decline versus placebo, as defined by the Clinical Dementia Rating-Sum of Boxes test. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.