Fennec Pharma gets European marketing authorization for Pedmarqsi to reduce the risk of hearing loss
Fennec Pharmaceuticals Inc., a commercial stage specialty pharmaceutical company, announced Pedmarqsi– known as Pedmark in the US – was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localised, non-metastatic, solid tumours. Further, Pedmarqsi was granted the marketing authorization under the paediatric-use marketing authorization (PUMA) which includes 8 years plus 2 years of data and market protection.
“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 tumors that have not spread,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “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 per cent of children treated with cisplatin and can be as high as 90 per cent. We look forward to making this important treatment available to the paediatric oncology community in the EU as soon as possible.”
