Chugai Reports the NDA Submission of Crovalimab to the MHLW for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Japan
Shots:
- The application was based on the P-III study (COMMODORE 1 & 2) evaluating crovalimab (anti-C5 recycling Ab) vs eculizumab (SC, q4w or IV, q2w) in a ratio (1:1) & (2:1) in 89 & 204 patients aged <18yrs. The studies were conducted in collaboration with Roche
- In the (COMMODORE 2) study, 79.3% vs 79.0% achieved haemolysis control from 5wk. to 25wk., transfusion avoidance (65.7% vs 68.1%) from baseline to 25wk., improvement in FACIT-fatigue score from baseline to 25wk.
- AEs (78% vs 80%), serious inf. (3% vs 7%) with no meningococcal inf., 1 patient experienced an AE leading to treatment discontinuation. The (COMMODORE 1) study results showed maintained disease control who switched from currently approved complement inhibitors. The clinical trials are ongoing for aHUS, SCD & lupus nephritis
Ref: Chugai | Image: Chugai
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