Norgine Secures TGA Approval for PEDMARQSI® in Australia

Norgine, a European pharmaceutical company, announced the Australian registration of PEDMARQSI® by the Therapeutic Goods Administration (TGA). This development targets cisplatin-induced hearing loss in children aged 1 month to under 18 with localized, non-metastatic solid tumors. Cisplatin, though essential in treating pediatric tumors, poses a risk of permanent hearing impairment, significantly affecting children's quality of life.

General Manager Gus Rudolph highlighted the significance of this milestone in providing a preventive option for hearing loss, a known complication of cisplatin therapy. The registration draws on data from two Phase 3 clinical trials. PEDMARQSI® is the first approved treatment of its kind in Australia and enjoys prior recognition in Europe, the UK, and Switzerland.

While not yet included in the Pharmaceutical Benefits Scheme, PEDMARQSI®'s approval reflects Norgine's progression in offering solutions for unmet medical needs. This achievement underscores its capabilities in managing regulatory challenges for specialized medicines.