Fennec Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Pedmarqsi for Cisplatin-Induced Ototoxicity in Pediatric Patients
- The EMA’s CHMP has issued a positive opinion recommending the marketing authorization of Pedmarqsi (sodium thiosulfate) in the US for the prevention of ototoxicity (hearing loss) induced by cisplatin CT in patients aged 1mos. to <18yrs. with localized, non-metastatic, solid tumors
- The opinion was based on the 2 P-III trials (SIOPEL 6) and (COG Protocol ACCL0431) evaluating Pedmarqsi + cisplatin-based regimen vs cisplatin-based regimens alone. The results from both studies showed that the hearing loss incidence rate was lower in the Pedmarqsi + cisplatin arm vs cisplatin alone (28.6% vs 56.4%) & (35.1% vs 67.3%)
- The EC will review the CHMP's recommendation & issue a decision on Pedmarqsi’s approval by early June 2023. Pedmarqsi is currently marketed as Pedmark in the US
Ref: Globenewswire | Image: Fennec
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