The European Commission (EC) has granted marketing authorisation for Fennec Pharmaceuticals’ Pedmarqsi (sodium thiosulfate) to reduce the risk of hearing loss in paediatric oncology patients.
Known as Pedmark in the US, Pedmarqsi is the first and only therapy to receive approval in the European Union to prevent cisplatin chemotherapy-induced hearing loss (ototoxicity) in patients aged between one month and 18 years with localised, non-metastatic solid tumours.
It received marketing approval under the paediatric-use marketing authorisation that provides ten years of protection, including protection of data and market.
Fennec Pharmaceuticals CEO Rosty Raykov stated: “Today’s approval by the European Commission for Pedmarqsi to help reduce the risk of hearing loss is critical for the approximately four thousand children treated with cisplatin for solid tumours that have not spread.
“Fennec is proud to bring this safe and effective therapy to the marketplace to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60% of children treated with cisplatin and can be as high as 90%.
“We look forward to making this important treatment available to the paediatric oncology community in the EU as soon as possible.”
The regulatory approval comes after a positive opinion issued by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) in March 2023.
The CHMP’s opinion was based on the findings obtained from two randomised, open-label, pivotal Phase III trials (SIOPEL 6 and clinical oncology group [COG] protocol ACCL0431).
These trials compared a Pedmarqsi with a cisplatin-based regimen to a cisplatin-based regimen alone in reducing cisplatin-induced hearing loss in paediatric patients.
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