Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition

The COMMODORE 2 study met its co-primary efficacy endpoints, showingcrovalimab achieved disease control in people with paroxysmal nocturnalhaemoglobinuria (PNH) who have not been previously treated with complement inhibitorsThe results of the phase III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors, supported thefavourable benefit-risk profile ofcrovalimab, as seen in the pivotal COMMODORE 2 studyResults from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meetingBasel, 7 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal haemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, 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 III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalim...

Source: Roche Investor Update - February 7, 2023 Category: Pharmaceuticals Source Type: news