Shots:
- The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China
- Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 & 2EPs & demonstrated superiority over Soliris, incl. reaching a hemoglobin target of 12 g/dL in 59.5% vs 8.3% pts
- The trial also showed a greater hemoglobin increase from baseline (~5.0 vs 2.2 g/dL) & reduced transfusion requirements, with 94.6% vs 69.4% of pts remaining transfusion-free during the study
Ref: Globenewswire | Image: Nuvectis Pharma | Press Release
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