Swissmedic Approves IFINWIL® for High-Risk Neuroblastoma in Children

Swissmedic Grants Approval to IFINWIL® for Pediatric Neuroblastoma



On July 8, 2025, Norgine, a leading European pharmaceutical company, proudly announced that its drug, IFINWIL® (éflornithine), has received approval from Swissmedic for use as a monotherapy in treating high-risk neuroblastoma in pediatric patients aged one year and older. This milestone follows prior approvals in the United States, Israel, and Australia, marking significant progress in pediatric oncology.

Jörg Plessl, Norgine’s Vice President and Global Head of Regulatory Affairs, emphasized the importance of this approval, stating, "This regulatory milestone for IFINWIL® in high-risk neuroblastoma treatment demonstrates the commitment and understanding of Swissmedic and our collaborators in the Orbis project towards the unique challenges posed by pediatric oncology. The rapid and flexible use of adaptive regulatory mechanisms is critical when addressing life-threatening conditions in children. Here, timing isn’t just beneficial; it is vital."

The Orbis project, initiated by the FDA’s Oncology Center of Excellence, aims to streamline the approval process for innovative cancer treatments across various international regulatory bodies. By enabling simultaneous and collaborative submissions, Orbis focuses on accelerating patient access to effective therapies. Norgine is keen on expanding its reach in Europe and New Zealand to provide innovative treatments, reflecting their commitment to tackling complex diseases, driven by a mission to deliver meaningful healthcare solutions where they are most needed.

High-risk neuroblastoma is a rare but aggressive cancer type primarily affecting children under the age of five. Annually, approximately 10.2 out of every million children under 15 are diagnosed globally, with around 50% classified as high-risk at the time of diagnosis. This aggressive cancer often originates from neuroblasts—the nerve cells—and commonly appears as a primary tumor in the adrenal glands. Unfortunately, by the time of diagnosis, the disease has frequently metastasized, complicating treatment efforts.

Despite rigorous multimodal therapies, the five-year survival rate for children with high-risk neuroblastoma remains below 50%, contrasting sharply with over 95% for infants diagnosed with low-risk neuroblastoma. Neuroblastoma accounts for about 15% of all pediatric cancer fatalities, underscoring the immediate need for more effective treatment options.

IFINWIL® is designed to serve as a maintenance therapy for high-risk neuroblastoma patients in remission after receiving initial multimodal treatment. It functions by inhibiting an enzyme known as ornithine decarboxylase (ODC), critical in producing polyamines that support tumor growth and development.

Children diagnosed with high-risk neuroblastoma undergo intense treatment protocols, but they remain susceptible to recurrences and poor prognosis. The survival outlook is grim, with about 80% experiencing high-risk recurrence within two years of diagnosis, and only about 15% surviving past five years post-relapse. Preventing recurrences is paramount for long-term survival, but until now, no maintenance therapy has been approved on major markets outside the United States.

About Norgine



Norgine has been transforming patients' lives for more than a century, committed to providing innovative medicines that enhance healthcare. In 2022 alone, over 25 million patients benefited from their products, which generated €530 million in net sales—a nearly 5% increase from 2021. With direct operations in 16 European countries as well as Australia and New Zealand, Norgine is dedicated to delivering specialized and impactful therapies for various medical conditions.

This approval not only represents a breakthrough in the treatment of pediatric neuroblastoma but also reinforces Norgine's unwavering dedication to addressing pressing healthcare needs for some of the most vulnerable patients in our society.

Topics Health)

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