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Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for PEDMARK

~ Prescription Drug User Fee Act (PDUFA) target action date set for September 23, 2022 ~

RESEARCH TRIANGLE PARK, N.C., , April 27, 2022 (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 Company’s resubmitted New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients one month to <18 years of age with localized, non-metastatic, solid tumors. The PDUFA target action date for the NDA is September 23, 2022.

“We are pleased that the FDA has accepted our resubmission and we look forward to working with the Agency to facilitate their review of our NDA. If approved, PEDMARKTM has the potential to become a transformative treatment for pediatric patients at risk of cisplatin induced ototoxicity,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals.

PEDMARK has received both Breakthrough Therapy and Fast Track Designation by the FDA.

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 cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.  SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

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Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for PEDMARK ~ Prescription Drug User Fee Act (PDUFA) target action date set for September 23, 2022 ~RESEARCH TRIANGLE PARK, N.C., , April 27, 2022 (GLOBE NEWSWIRE) - Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, …

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