Fennec Pharmaceuticals’ Pedmarqsi (sodium thiosulfate) Receives EC’s Marketing Authorization for Cisplatin-Induced Ototoxicity
Shots:
- The EC has granted the marketing authorization for Pedmarqsi to prevent ototoxicity (hearing loss) induced by cisplatin CT in patients aged 1mos. to <18yrs. with localized, non-metastatic solid tumors
- The decision was based on 2 P-III trials (SIOPEL 6) & (COG Protocol ACCL0431) evaluating Pedmarqsi + cisplatin-based regimen vs cisplatin-based regimens alone. The results showed that the hearing loss incidence rate was lower in the Pedmarqsi + cisplatin arm vs cisplatin alone (28.6% vs 56.4%) in (COG ACCLO431) & 35.1% vs 67.3% in (SIOPEL6) studies
- The marketing authorization is valid for all 27 EU member states, Iceland, Norway, and Liechtenstein. Pedmarqsi is currently marketed as Pedmark in the US
Ref: Globenewswire | Image: Fennec
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
