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Norgine welcomes TGA registration in Australia of PEDMARQSI® (sodium thiosulfate anhydrous) for the prevention of cisplatin-induced hearing loss in children1

On Tuesday, May 5, 2026, the Australian Therapeutic Goods Administration registered PEDMARQSI for preventing cisplatin-induced hearing loss in children aged 1 month to <18 years with localised, non-metastatic solid tumours.
Cisplatin remains a crucial chemotherapy for children with solid tumours but carries substantial risk of permanent hearing loss, affecting speech development, education, and social functioning throughout life.
Registration relies on data from two open-label, randomised Phase III trials, SIOPEL 6 and COG ACCL0431. "Cisplatin induced hearing loss is a well recognised and often irreversible complication," said Dr. David Gillen, Chief Medical Officer, Norgine.
While PEDMARQSI is not currently included on the Pharmaceutical Benefits Scheme , it holds prior marketing authorisations in the United Kingdom, Switzerland, and the European Union since May 2023.
Norgine, an EU-based pharmaceutical company with 1,500 employees and approximately $650 million in annual sales, focuses on navigating regulatory pathways for rare and severe childhood diseases across Europe, Australia, and New Zealand.

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Norgine welcomes TGA registration in Australia of PEDMARQSI® (sodium thiosulfate anhydrous) for the prevention of cisplatin-induced hearing loss in children1

PEDMARQSI® is now TGA registered in Australia for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localised, non-metastatic, solid tumoursTGA

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