Roche’s PiaSky Receives the CHMP’s Positive Opinion for TreatingParoxysmal Nocturnal Haemoglobinuria (PNH)
Shots:
- The CHMP’s positive opinion of PiaSky for PNH adults & adolescents (≥12yrs., 40kg) was based on 3 P-III trials incl. COMMODORE 2 study of PiaSky (SC, Q4W) vs eculizumab (IV, Q2W) in patients not treated with C5 inhibitor; COMMODORE 1 study in subjects switched from C5 inhibitor & COMMODORE 3 study in Chinese subjects new to C5 inhibitor
- COMMODORE 2 study showed that the drug was superior, well-tolerated & attained disease control with 78% vs 80% AEs
- PiaSky (C5 protein inhibiting mAb) is currently being studied under 5 P-III clinical evaluations & 3 earlier phase studies to treat complement-mediated diseases such as PNH, atypical haemolytic uremic syndrome & sickle cell disease
Ref: Roche | Image: Roche
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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.
