Genentech, a member of the Roche, announced that the FDA has accepted the company’s Biologics License Application, or BLA, for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria, or PNH. The acceptance was based on results from the pivotal Phase III COMMODORE 2 study, which demonstrated that in people with PNH, crovalimab achieved disease control and was well-tolerated. Results from the Phase III COMMODORE 1 study, demonstrating the consistent benefit-risk profile of crovalimab, also supported the application.
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