Norgine Secures Australian Approval for PEDMARQSI in Paediatric Oncology Supportive Care

New updates have been reported about Norgine.

Norgine has obtained Australian Therapeutic Goods Administration (TGA) registration for PEDMARQSI (sodium thiosulfate anhydrous), positioning the company to expand its paediatric oncology supportive-care franchise in Australia. The product is now approved to prevent cisplatin-induced ototoxicity in patients aged one month to under 18 years with localised, non-metastatic solid tumours, addressing a critical unmet need in a niche but high-impact segment.

This is the first and only treatment registered in Australia for preventing hearing loss caused by cisplatin in paediatric patients, reinforcing Norgine’s strategy of focusing on specialist and rare-disease medicines. The decision is supported by Phase 3 data from the SIOPEL 6 and COG ACCL0431 trials, giving Norgine a robust clinical evidence base to support adoption and payer discussions.

Senior leadership at Norgine emphasised both the clinical and strategic significance of the approval, noting that cisplatin-related hearing loss has long-term implications for communication, education and quality of life in children. The company’s Australian management has flagged its intent to work with stakeholders to secure access pathways, although PEDMARQSI is not yet listed on the Pharmaceutical Benefits Scheme (PBS), which will be a key determinant of volume and revenue upside.

The TGA registration complements earlier regulatory wins for PEDMARQSI, including a Paediatric Use Marketing Authorisation from the European Medicines Agency, national approval in the United Kingdom, and a Swissmedic authorisation granted in March 2026. Collectively, these approvals signal that Norgine is building a multi-region paediatric oncology support portfolio, leveraging its development and commercial platform across Europe, Australia and New Zealand.

With approximately $650 million in annual sales and a mid-sized footprint of about 1,500 employees, Norgine is using PEDMARQSI to deepen its presence in oncology-adjacent supportive care while reinforcing its capability to navigate complex regulatory paths. The Australian approval expands the addressable market for PEDMARQSI and strengthens Norgine’s rare and specialist-medicines positioning, though near-term financial impact will depend heavily on future PBS reimbursement and hospital formulary uptake.

For executives and investors, the TGA decision underscores Norgine’s execution on a strategy centred on high-barrier, specialist therapies rather than broad primary-care products. The company now has aligned regulatory platforms across key European markets and Australia for PEDMARQSI, creating optionality for further geographic expansion, partnership discussions and potential lifecycle management initiatives in paediatric oncology supportive care.