Fennec Receives Positive CHMP Opinion For Pedmarqsi In Pediatric Oncology Patients

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi for the prevention of hearing loss induced by cisplatin chemotherapy in pediatric oncology patients. Pedmarqsi is known as Pedmark in the U.S. and FDA has approved it in September 2022.

Pedmarqsi, once approved by the European Commission, will be the first treatment for this unmet medical need. The specialty pharmaceutical company said, children treated with cisplatin for solid tumours carry a very high risk of losing their hearing permanently.

The CHMP's recommendation will now be reviewed by the European Commission, and ratification is expected by early June 2023.