Fennec receives positive CHMP opinion for Pedmarqsi

Fennec Pharmaceuticals 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 – known as PEDMARK in the U.S. – for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than18 years of age with localized, non-metastatic, solid tumors. When formally approved by the European Commission, Pedmarqsi will be the first and only treatment approved in the European Union to address this area of significant unmet medical need. "There are currently no approved treatments in Europe to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.1 The CHMP positive opinion brings European patients and their families closer to having a preventive treatment option to prevent the devastating consequences of hearing loss following the use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "With approximately five thousand children eligible for treatment with a platinum-based chemotherapy each year in Europe, we are excited by the potential this therapy can offer to the pediatric oncology community."