Fennec Pharmaceuticals Inc (NASDAQ:FENC) announced recently that the US Food and Drug Administration (FDA) has approved the PEDMARK™ a Breakthrough Therapy designation for treatment of cisplatin-related ototoxicity condition in pediatric patients. The announcement made the company shares to go up by 18%. In addition, the company announced recently its quarterly and year-round financial results at the beginning of the week as it prepares for its first commercial launch of the drug candidate during the second half of 2019.
Cisplatin are basically the chemotherapeutic components related to various pediatric tumors that can cause ototoxicity in patients with pediatric cancer. About 10,000 children in the US and Europe receive the platinum-based chemotherapy annually. Therefore, with the new designation, the patients would obtain lifelong hearing aids particularly after undergoing chemotherapy.
FDA granted PEDMARK the unique formulation of sodium thiosulfate due to the potential efficacy and safety data that were generated recently from both the SIOPEL 6 and COG ACC431 research studies. The latest designation indicates that the organization availed sufficient preliminary clinical evidence that influenced the FDA to approve the drug.
The designation is effective than the currently available treatments on the market. Furthermore, it has similar benefits found in the Fast Track designation that has been recognized by FDA. Also, the current designation comprise of all the Fast Track designation features together with the intensive FDA guidelines for efficient drug development.
Fennec had just received the Fast Track designation recently before being granted the Breakthrough Therapy designation, which reflects highly on the overwhelming need to deal with the serious medical condition that is currently responsible for increasing cases of hearing loss in child cancer patients.
According to Rosty Raykov, President and CEO of Fennec, the Breakthrough Therapy designation is the greatest milestone for the company as it plans to collaborate with the FDA to accelerate the NDA filing. Generally, FDA approves the drug or designation that has clear preliminary clinical evidence of effective healing, with significant improvement than the available treatments in curing a chronic condition.