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Fennec Pharmaceuticals Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MAA) to European Medicines Agency
PEDMARK™ is Being Developed for Prevention of Cisplatin-Induced Hearing Loss in Children RESEARCH TRIANGLE PARK, N.C., Feb. 11, 2020 (GLOBE NEWSWIRE) --
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"PEDMARK™ is Being Developed for Prevention of Cisplatin-Induced Hearing Loss in Children\nRESEARCH TRIANGLE PARK, N.C., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 \n 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 3 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. “At Fennec, we are dedicated to the development of PEDMARK for the prevention of ototoxicity in children. The completion of these regulatory submissions to the FDA and EMA are the culmination of many years of hard work, bringing us one step closer to achieving our mission,” said Rosty Raykov, chief executive officer of Fennec. “Fennec would like to thank the many parents, children and investigators who participated in the clinical trials, as well as our dedicated employees who helped us reach this important milestone. We are well underway with commercialization readiness activities to support the potential launch of PEDMARK and our transition to becoming a commercial-stage organization.” The FDA has a 60-day review period to determine whether the PEDMARK NDA is acceptable for filing. PEDMARK has been granted Orphan Drug, Breakthrough Therapy, and Fast Track designations from the FDA. If PEDMARK is granted a priority review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of 202...