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Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for PEDMARK™
~ Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ NDA Resubmission for PEDMARK for the Prevention of
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":" ~ Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ NDA Resubmission for PEDMARK for the Prevention of Cisplatin-Induced Ototoxicity for Pediatric Patients with Localized, Non-Metastatic Solid Tumors ~ ~ If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ RESEARCH TRIANGLE PARK, N.C., June 22, 2021 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to November 27, 2021. “We are pleased that the FDA has accepted our PEDMARK™ resubmission,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. “We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARK™ stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.” PEDMARK has been granted both Fast Track Designation and Breakthrough Therapy Designation by the FDA. The Complete Response Letter (CRL) received on August 10, 2020, referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data. About PEDMARK™ Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer. In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity 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 coc...