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Fennec Pharmaceuticals Receives Positive CHMP Opinion for Pedmarqsi™ (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients
~ First Therapy Recommended for Approval in the European Union for Reducing the Risk of Cisplatin-induced Hearing Loss (Ototoxicity) in Pediatric Patients
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ First Therapy Recommended for Approval in the European Union for Reducing the Risk of Cisplatin-induced Hearing Loss (Ototoxicity) in Pediatric Patients with Localized, Non-metastatic Solid Tumors~ ~ Positive CHMP Opinion Based on Clinical Results Demonstrating Prevention of Ototoxicity and a Favorable Benefit-Risk Profile With Pedmarqsi~ ~ Pedmarqsi is Currently Marketed as PEDMARK® in the U.S. Following FDA-Approval in September 2022 ~ RESEARCH TRIANGLE PARK, N.C., March 31, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi™ (sodium thiosulfate) – known as PEDMARK® in the U.S. – for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to 5% compared to cisplatin alone) in SIOPEL6 were vomiting, infection, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia. The CHMP's recommendation will now be reviewed by the European Commission, ratification of the CHMP recommendation is expected by early June 2023. PEDMARK was approved by the U.S. Food and Drug Administration (FDA) in September 2022. About Cisplatin-Induced Ototoxicity Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.2 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.3 Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.4 PEDMARK® (sodium thiosulfate injection)PED...