Fennec: PDCO accepts pediatric investigation plan for PEDMARK
Fennec Pharmaceuticals announced that the Pediatric Committee of the European Medicines Agency has accepted the company's pediatric investigation plan for PEDMARK for the condition of the prevention of platinum-induced ototoxic hearing loss. The indication targeted by the PIP is for the prevention of platinum-induced ototoxic hearing loss for standard risk hepatoblastoma. Additional tumor types of the proposed indication will be subject to the Committee for Medicinal Products for Human Use assessment at the time of the Marketing Authorization Application. The company was also advised that PEDMARK is eligible for submission of an application for a Pediatric Use Marketing Authorisation. PEDMARK has been granted Orphan Drug, Breakthrough Therapy, and Fast Track Designations in the United States by the FDA.