Roche ’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition

The phase III COMMODORE 3 study ofcrovalimab met primary endpoints of transfusion avoidance andhaemolysis control in people with paroxysmal nocturnal hemoglobinuria (PNH)1COMMODORE 3 is the first China-specific study in PNH. Current treatment options are extremely limited in China, resulting in significant levels of disease-related morbidity and mortality for people living with PNH2Based on these datacrovalimab has received Breakthrough Therapy Designation and is under Priority Review for approval in ChinaBasel, 11 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody, is efficacious and well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH). The study met its co-primary efficacy endpoints of transfusion avoidance (TA) and haemolysis control, demonstrating that participants with PNH, who have not been treated previously with complement inhibitors and who received subcutaneous crovalimab injections every four weeks, achieved disease control.1 The data were presented at the American Society of Hematology (ASH) congress, taking place from 10-13 December 2022.PNH is an ultra-rare and life-threatening blood condition, where red blood cells are targeted and destroyed by the complement system — part of the innate immune system — causing symptoms such as anaemia, fatigue, blood clots and kidney disease.3 C5 in...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news