Shots:
- The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve
- Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients switching from C5 inhibitors) & COMMODORE 3 (new to C5 inhibitor treatment in China)
- COMMODORE 2 showed PiaSky (SC, Q4W) controlled disease, was well-tolerated & non-inferior to eculizumab (C5 inhibitor, given IV, Q2W) with similar safety profiles & AE rates
Ref: Roche | Image: Roche| Press Release
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