Regulatory fast track for drug that targets chemotherapy-related hearing loss
FDA
Fennec Pharmaceuticals Inc., a small biotech operating from Durham, North Carolina, USA recently announced that it has been granted fast-track designation by the US FDA for its signature drug Pedmark (a unique formulation of sodium thiosulfate), WRALTechWire reports.
Pedmark is being developed as a treatment for hearing loss among children who receive chemotherapy. The fast-track status makes it possible to accelerate the review process and to work more closely with the Agency.
“In the US and Europe, [it] is estimated that over 10,000 children may receive platinum-based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear implants have been shown to provide some benefit.”
In other good news for the company and hopefully for the affected children, the FDA also granted Fennec breakthrough therapy designation for the candidate drug. The company says that promising efficacy and safety data from the SIOPEL 6 and COG ACCL0431 studies in the prevention of cisplatin-induced ototoxicity underpin this decision. Breakthrough therapy designation is given when a treatment may represent substantial improvement over available therapies for a serious condition.
Source: WRALTechWire
