Pedmark filed with EU and rolling submission completed with FDA for hearing loss.- Fennec Pharma

Fennec Pharmaceuticals announced it has completed its rolling submission of a New Drug Application (NDA) to the FDA for Pedmark (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined). The Pedmark indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.Fennec’s Pedmark regulatory submissions follow: a pre-NDA meeting with the FDA in December 2018 after which Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and an approved pediatric investigation plan (PIP). Both applications are based upon clinical results from two pivotal Phase III clinical trials: SIOPEL 6 conducted by the International Childhood Liver Tumor Strategy Group (SIOPEL) with results published in the New England Journal of Medicine in June 2018 and ACCL0431 conducted by the Children’s Oncology Group (COG) with results published in Lancet Oncology in 2016.