Research & Development
Norgine submits first marketing authorisation application submissions for approval of eflornithine
16 April 2024 -

Norgine BV, a Netherlands-based specialist pharmaceutical company, announced on Monday that it has submitted its first marketing authorisation application submissions on 10 April 2024 for the approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis, in Australia, Switzerland and the United Kingdom.

The company says that this move supports its efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology.

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

On 13 December 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for HRNB, indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies

Dr David Gillen, Norgine's chief medical officer, said, '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.'