Home Alzheimer’s Disease FDA Grants Priority Review to Sodium Thiosulfate for Ototoxicity Prevention

FDA Grants Priority Review to Sodium Thiosulfate for Ototoxicity Prevention

The FDA has granted priority review to the new drug application (NDA) for sodium thiosulfate (Pedmark) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors, according to Fennec Pharmaceuticals, the drug’s developer.1

A prescription drug user fee act (PDUFA) target action date of August 10, 2020 was set by the FDA for the completion of the review.

“The FDA filing acceptance of our NDA and granting of priority review represents a significant milestone in the development of Pedmark and we look forward to working closely with the Agency during this review process,” Rosty Raykov, chief executive officer of Fennec, said in a press release. 

Sodium thiosulfate has been studied by cooperative groups in 2 phase III clinical studies of survival and reduction of ototoxicity, The Clinical…

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