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Roche: FDA accepts application for Roche's crovalimab
(CercleFinance.com) - Roche announced today that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal haemoglobinuria (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. Copyright (c) 2023 CercleFinance.com. All rights reserved. |
30/05/2025 18:02
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