#Switzerland #Neuroblastoma #Norgine #IFINWIL #Ubxbridge

Swissmedic Grants Approval for IFINWIL®

In a significant development for pediatric cancer treatment, Swissmedic has officially approved the registration of IFINWIL® (eflornitina) as a monotherapy for high-risk neuroblastoma (HRNB) in children aged one and older. Norgine, a leading European specialty pharmaceutical company, has expressed its enthusiasm regarding this advancement, which follows the earlier approvals received in the US, Australia, and Israel.

Jörg Plessl, Vice President and Global Head of Regulatory Affairs at Norgine, stated, "This milestone signifies a crucial regulatory approval for IFINWIL® in the field of pediatric oncology. We extend our deepest gratitude to Swissmedic and our partners involved in Project Orbis for their expertise regarding the challenges posed by pediatric oncology. The swift and flexible routes employed here are vital, especially when children’s lives are at stake."

The Urgent Need for Effective Treatments

High-risk neuroblastoma is an aggressive and rare form of cancer primarily affecting children, especially those under the age of five. Approximately 10.2 children per million are diagnosed annually worldwide, with around 50% classified as high-risk upon initial diagnosis. The condition typically originates from neuroblasts, nerve cells that develop into tumors, most commonly found in the adrenal glands, and often metastasizes to other body areas.

Despite intensive multimodal therapies, the five-year survival rate for HRNB remains below 50%, starkly contrasted with over 95% survival for infants diagnosed with low-risk disease. Neuroblastoma constitutes roughly 15% of all pediatric cancer-related fatalities, highlighting the pressing demand for innovative and effective treatment options.

Innovative Mechanism of IFINWIL®

IFINWIL® has been specifically researched for use as a maintenance therapy following the initial multimodal treatment in pediatric patients with no active disease. This innovative therapy works by inhibiting an enzyme called ornithine decarboxylase (ODC), which is essential for the production of polyamines. These compounds play a vital role in tumor growth and development.

Children diagnosed with HRNB undergo a rigorous treatment regimen, yet many remain vulnerable to relapses. While there have been marginal improvements in survival rates, the prognosis for these children remains bleak, with around 80% of high-risk relapses occurring within two years after diagnosis and a mere 15% surviving beyond five years post-relapse.

The Role of Project Orbis

Launched in May 2019, Project Orbis is an initiative by the FDA's Oncology Center of Excellence aimed at facilitating simultaneous and collaborative reviews of innovative oncology products across international regulatory authorities. Its overarching goal is to expedite patient access to breakthrough cancer therapies worldwide. Norgine’s participation in this initiative has been pivotal in advancing their strategy to expand access to innovative treatments for pediatric patients across Europe, Australia, and New Zealand.

In April 2024, Norgine submitted an approval application for eflornitina targeting HRNB through Project Orbis in Australia, Switzerland, and the UK. Following subsequent approval by the Australian Therapeutic Goods Administration (TGA) in April 2025, the journey toward providing additional treatment options in pediatric oncology gained momentum.

Norgine’s Commitment to Improving Lives

Norgine's legacy spans over a century, during which the company has dedicated itself to delivering innovative medicines to patients. Driven by a mission to transform lives, the company prides itself on addressing some of the most complex diseases. In 2022 alone, Norgine reported helping over 25 million patients worldwide, generating 530 million euros in net sales—a near 5% increase from 2021.

With a robust footprint across 16 European countries, alongside Australia and New Zealand, Norgine’s integrated infrastructure and flexible approach empower it to provide crucial medications that truly make a difference in patients' lives. As the healthcare landscape evolves, Norgine reaffirms its commitment to pioneering solutions in pediatric oncology and beyond.

As the approval of IFINWIL® marks a pivotal moment in pediatric cancer treatment, it reflects a dedication to facilitating better outcomes for the youngest and most vulnerable patients battling this challenging disease. The journey doesn't end here; continual efforts are required to innovate and enhance the therapeutic landscape for high-risk neuroblastoma.