Fennec receives positive CHMP opinion for Pedmarqsi to prevent cisplatin-induced hearing loss in pediatric patients

FENNEC PHARMACEUTICALS INC.

CHMP recommends EU marketing authorization for Pedmarqsi (sodium thiosulfate) to prevent ototoxicity in pediatric patients aged 1 month to <18 years with localized solid tumors.
Phase 3 trial SIOPEL 6 showed hearing loss in 28.6% with Pedmarqsi vs 56.4% with cisplatin alone (p=0.004).
European Commission decision expected by early June 2023; Pedmarqsi is already FDA-approved as PEDMARK in the U.S.
Approximately 5,000 children in Europe annually eligible for platinum-based chemotherapy could benefit from this therapy.

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