- Roche Holdings AG RHHBY has announced results from the global phase 3 COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in treatment-naive people with paroxysmal nocturnal hemoglobinuria (PNH).
- The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels).
- Also Read: Roche Flags Lower 2023 Sales On Declining Demand For COVID-19 Treatment, Diagnostics.
- Results showed that crovalimab, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks.
- The efficacy and safety data from the separate phase 3 COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalimab, supported the favorable benefit-risk profile of crovalimab, as seen in the pivotal COMMODORE 2 study.
- PNH is a rare and life-threatening condition in which the complement system destroys red blood cells.
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