Norgine, a Netherlands-based specialty pharmaceutical and consumer healthcare company, announced on Tuesday that it has completed its marketing authorisation application filing to the European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB).

This follows the submissions in April 2024 through Project Orbis, in Australia, Switzerland and the United Kingdom.

Norgine said that this milestone further supports its efforts to give patients access to eflornithine and bring a further treatment option in the field of paediatric oncology.

Under an exclusive licensing agreement with USWM LLC (dba US WorldMeds), a Kentucky-based specialty pharmaceutical company, Norgine will register and commercialise eflornithine, also referred to as DFMO, in Europe, Australia and New Zealand.

The US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for HRNB in December 2023. The product is indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies.