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FDA Alerts
Hematology

FDA accepts BLA application for Genentech’s rare blood condition treatment

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The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for crovalimab (Genentech), an innovative anti-C5 recycling monoclonal antibody, according to a press release.

The acceptance was based on promising results from the Phase 3 COMMODORE 2 study, demonstrating crovalimab’s efficacy and high tolerance in individuals with PNH. Additionally, the Phase 3 COMMODORE 1 study further supported the application, highlighting the consistent benefit-risk profile of the treatment.

Results from the COMMODORE 2 study indicated that crovalimab, administered as subcutaneous injections every 4 weeks, was non-inferior in terms of safety and efficacy compared to the current standard of care, eculizumab. Adverse events were reported in 78% of participants treated with crovalimab and 80% treated with eculizumab, with the most common event being an infusion-related reaction.

PNH is a rare and life-threatening blood disorder affecting around 20,000 people worldwide. It leads to the destruction of red blood cells by the complement system, causing symptoms such as anemia, fatigue, blood clots, and potential kidney disease.

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