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Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.
Roche, a Swedish biotechnology company, announced on Feb. 7, 2023 positive data from its Phase III study (COMMODORE 2) evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, in people with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood condition that causes the complement system to destroy red blood cells. The treatment is for PNH patients who have not been previously treated with complement inhibitors.
According to a company press release, crovalimab is designed to control PNH via a subcutaneous injection every four weeks. In this study, crovalimab met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis, or the ongoing destruction of red blood cells. Study results indicated that the drug achieved disease control and was non-inferior to eculizumab, a current standard of care given intravenously every two weeks.
“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche, in the release. “As the first global [P]hase III data for crovalimab, these results emphasize its potential to address these needs. We look forward to submitting these data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world.”