Fennec Pharmaceuticals Inc. has submitted a rolling new drug application to the U.S. Food and Drug Administration seeking approval to market its drug that prevents hearing loss resulting from chemotherapy.
Fennec's Pedmark, a formulation of sodium thiosulfate, deactivates the metabolic consequences of platinum compounds used in chemotherapy and prevents toxicity in the ear that can cause temporary or permanent hearing loss. The drug is under development to treat patients between one month to 18 years of age and has been evaluated in two late-stage trials, COG ACCL0431 and SIOPEL 6.
The FDA previously granted Fennec breakthrough therapy status and fast-track designation for Pedmark. The breakthrough therapy designation will include an accelerated review process, as well as more intensive FDA guidance on an efficient drug development program.
Fennec expects to get approval for Pedmark from the FDA in the second half of 2019 and will also submit a marketing application to the European Medicines Agency. The EMA's Paediatric Committee responsible for children's medicines recently approved a pediatric investigation plan for Pedmark.
Research Triangle Park, N.C.-based Fennec is a biopharmaceutical company that develops product candidates for use in treating cancer in the U.S.