Genentech Reports the US FDA Acceptance of BLA for Crovalimab to Treat Paroxysmal Nocturnal Hemoglobinuria
Shots:
- The US FDA has accepted the BLA for crovalimab for PNH. The acceptance was based on the P-III trial (COMMODORE 2) evaluating crovalimab (SC, q4w) vs eculizumab (IV, q2w) in a ratio (2:1)
- The results showed that patients achieved disease control & were non-inferior to eculizumab, and AEs (78% vs 80%). The application also includes the P-III study (COMMODORE 1) results supported the favorable benefit-risk profile of crovalimab in patients switching from currently approved C5 inhibitors
- Both studies' results were presented at the EHA 2023 & submitted to other regulatory authorities globally. The therapy is being studied in a broad clinical development program incl. 5 ongoing P-III studies & 3 earlier phase studies in PNH & other complement-mediated diseases
Ref: Businesswire | Image: Genentech
Related News:- Chugai Reports the NDA Submission of Crovalimab to the MHLW for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Japan
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