Roche’s PiaSky Receives the EC’s Approval to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH)
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- 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
Related News:- Roche’s PiaSky Receives the CHMP’s Positive Opinion for TreatingParoxysmal Nocturnal Haemoglobinuria (PNH)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
