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 | Press Release
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