#Switzerland #Eflornithine #Norgine #IFINWIL® #Ubxbridge

Swissmedic Grants Approval for IFINWIL® (Eflornithine) in Pediatric High-Risk Neuroblastoma

On July 8, 2025, Swissmedic, the Swiss Agency for Therapeutic Products, granted approval for IFINWIL® (Eflornithine) as a monotherapy for treating high-risk neuroblastoma (HRNB) in pediatric patients aged one year and older. This decision has been announced by Norgine, a leading European specialty pharmaceutical company. This approval is especially significant as neuroblastoma predominantly affects children, with about 90% of cases occurring in children under the age of five. Tragically, the average survival rate for those diagnosed with HRNB sits at a mere 50%, highlighting the urgent need for effective treatment options.

According to Jörg Plessl, Vice President and Head of Global Regulatory Affairs at Norgine, this achievement marks another step forward in gaining regulatory approval for IFINWIL® following its clearances in the USA, Israel, and Australia. Plessl expressed gratitude to Swissmedic and the project's partners involved in Project Orbis, emphasizing the critical nature of their understanding of the challenges within pediatric oncology. “When dealing with children's health and lives, speed and flexibility can make a crucial difference,” he stated.

Dr. David Gillen, Chief Medical Officer at Norgine, elaborated on the significance of collaborating with international regulatory bodies under Project Orbis to enhance access to innovative therapies for young patients across Europe, Australia, and New Zealand. Norgine focuses on providing meaningful treatments in the most complex disease areas where they are most needed.

High-risk neuroblastoma is a rare and aggressive type of cancer that primarily affects young children, typically presenting in the first five years of life. Each year, around 10,200 children globally under 15 years are diagnosed with neuroblastoma, with about half classified high-risk at the time of diagnosis. The disease arises from nerve cells (neuroblasts) and most often manifests as a primary tumor in the adrenal glands. Due to its aggressive nature, neuroblastoma often metastasizes and spreads to other parts of the body. By the time of diagnosis, it is frequently advanced, complicating treatment efforts.

Despite the use of intensive multimodal therapies, the five-year survival rate for HRNB remains under 50%, in stark contrast to more than 95% for low-risk cases. Neuroblastomas account for approximately 15% of all cancer-related deaths in children, emphasizing the urgent need for more effective treatment options.

Information on IFINWIL®

IFINWIL® has been researched as a maintenance therapy for HRNB in pediatric patients who show no active disease (NAD) or no evidence of disease (NED) after an initial multimodal treatment. The therapy works by blocking an enzyme called ornithine decarboxylase (ODC), which is crucial for the production of polyamines, substances essential for tumor growth and development.

Understanding High-Risk Neuroblastoma Treatment

Children diagnosed with HRNB undergo rigorous treatments that often render them susceptible to relapses and mortality. Improvements in survival rates have been noted; however, the prognosis for these children remains grim. Notably, about 80% of high-risk relapses occur within two years post-diagnosis, and long-term survival rates are disheartening, with only approximately 15% enduring beyond five years after recurrence. Preventing relapse plays a pivotal role in aspirations for long-term survival, yet no approved therapies currently exist for the post-maintenance phase outside the U.S.

About Project Orbis

Project Orbis, initiated in May 2019 by the U.S. FDA Oncology Center of Excellence (OCE), provides a framework for the parallel submission and collaborative review of innovative oncology products by international regulatory agencies. Its overarching aim is to accelerate patient access to novel cancer treatments worldwide. The project is coordinated by the FDA in partnership with regulatory authorities from the UK, Canada, Australia, Switzerland, Brazil, and Israel.

In April 2024, Norgine submitted an application for Eflornithine concerning HRNB via Project Orbis in Australia, Switzerland, and the UK. By April 2025, the Australian Therapeutic Goods Administration (TGA) approved IFINWIL® for treating both adult and pediatric patients with HRNB who have responded to prior multimodal therapy with multiple agents.

These regulatory milestones support Norgine's objectives of ensuring broader patient access to IFINWIL® and establishing another viable treatment option within pediatric oncology.

About Norgine

Norgine has been a leading European specialty pharmaceutical company delivering innovative medications to patients for over a century. Driven by a commitment to improving the quality of life, Norgine employs its extensive experience in Europe, an integrated infrastructure, and a collaborative approach to swiftly implement creative solutions, thereby providing patients with essential therapies. As of 2022, Norgine has helped over 25 million patients globally, achieving a net product revenue of €530 million, an increase of nearly 5% from 2021. Norgine directly operates in 16 European countries and maintains a strong global partnership network in regions outside of Europe, demonstrating its commitment to advancing healthcare and providing impactful solutions to patients’ needs.