Swissmedic Approves PEDMARQSI® for Preventing Hearing Loss in Children

Norgine has announced that Swissmedic has approved PEDMARQSI® (sodium thiosulfate) for preventing cisplatin-induced hearing loss in young patients with non-metastatic, solid tumors. This marks the first authorized treatment in Switzerland for children aged 1 month to under 18 years facing cisplatin chemotherapy. The approval addresses a significant unmet medical need, as cisplatin, while effective, poses a risk for irreversible hearing damage.

Clinical evidence from the pivotal SIOPEL 6 trial and the Clinical Oncology Group ACCL04313 trial showed that PEDMARQSI® reduced the incidence of hearing loss by approximately 50%, maintaining chemotherapy efficacy. The treatment has received prior approvals from the European Medicines Agency and the UK, highlighting Norgine's navigational success through varied European regulatory landscapes.