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Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
RESEARCH TRIANGLE PARK, N.C., Nov. 30, 2021 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., Nov. 30, 2021 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on November 29, 2021 from the U.S. Food and Drug Administration (FDA), after the PDUFA target action date of November 27, 2021, regarding its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥ 1 month to 18 years of age with localized, non-metastatic, solid tumors. The CRL was issued as a result of identified manufacturing deficiencies which need to be satisfactorily resolved before the Pedmark NDA can be approved. Fennec plans to request a Type A meeting with the FDA to discuss these deficiencies and other matters described in the CRL, as well as the steps required for the resubmission of the NDA for PEDMARK™. “We are steadfast in our commitment to reducing the risk of life-long hearing loss for children and young adults receiving cisplatin chemotherapy who currently have no approved therapies for this devastating condition,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “We will work closely with our current manufacturer as well as the FDA to fully address the issues raised in the letter. In addition, we continue to advance our second drug product manufacturing facility.” As of September 30, 2021, Fennec has existing cash and cash equivalents, which totaled approximately $24 million. About PEDMARK™ (A unique formulation of sodium thiosulfate (STS)) 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 is particularly harmful to the survivors of pediatric cancer. In the U.S. and Europe, it is estimated that, annually, more than 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 type of hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants ...