Pharma Focus Asia

Fennec Pharmaceuticals Receives U.S. FDA Orphan Drug Exclusivity for Pedmark® (Sodium Thiosulfate Injection)

Wednesday, February 01, 2023

Fennec Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity to PEDMARK® (sodium thiosulfate injection), indicated to reduce the risk of ototoxicity, or hearing loss, associated with cisplatin use in paediatric patients one month of age and older with localised, non-metastatic solid tumours.

PEDMARK® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to lower the risk of ototoxicity associated with cisplatin treatment in paediatric patients with localised, non-metastatic, solid tumours. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in paediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomised Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

The seven-year marketing exclusivity for PEDMARK® began on September 20, 2022, when approved by the FDA, will continue until September 20, 2029.

The Orphan Drug Exclusivity granted to PEDMARK®, represents an important breakthrough treatment option for the paediatric cancer community.

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