Fennec Pharmaceuticals Announces European Commission Marketing Authorization for Pedmarqsi (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients

Author: Benzinga Newsdesk | June 06, 2023 05:45am

Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a commercial stage specialty pharmaceutical company, today announced Pedmarqsi™– known as PEDMARK® in the U.S. – 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 tumors. 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.

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