NorgineNorgine seeks approval for high-risk neuroblastoma treatment
引进/卖出上市批准临床结果临床3期
来源: Pharmaceutical Technology
Eflornithine received approval from the US FDA as the first oral maintenance therapy for high-risk neuroblastoma. Credit: Kateryna Kon / Shutterstock.com.
Norgine has sought approval for eflornithine (difluoromethylornithine [DFMO]) for the treatment of patients with high-risk neuroblastoma (HRNB).
The development marks the first marketing authorisation applications submitted in Australia, Switzerland and the UK seeking approval for the drug.
The move is part of the Project Orbis initiative, aiming to expedite patient access to new treatment options.
Norgine has an exclusive licensing partnership with speciality pharmaceutical company US WorldMeds, under which Norgine will execute the registration and commercialisation activities of eflornithine in Europe, Australia and New Zealand.
Eflornithine received approval from the US Food and Drug Administration (FDA) as the first oral maintenance therapy for HRNB on 13 December 2023.
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It is indicated to reduce the relapse risk in adult and paediatric patients who have previously received therapies.
The FDA’s decision was informed by comparative results from the investigational arm of Study 3b and a clinical-trial-derived external control arm of Study ANBL0032.
The findings demonstrated that eflornithine treatment improved event-free survival and overall survival rates in patients with HRNB. These outcomes were notably better than those observed in patients treated with the standard of care without eflornithine.
Norgine chief medical officer Dr David Gillen stated: “These submissions via Project Orbis represent an important first step in the regulatory process for eflornithine and re-emphasise Norgine’s passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need.”
Last month, Norgine and Fennec Pharmaceuticals signed an exclusive licence agreement for the marketing of hearing loss therapy Pedmarqsi for paediatric cancer patients undergoing chemotherapy.
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