Roche Receives FDA Approval for Piasky in Paroxysmal Nocturnal Hemoglobinuria

Roche today announced that the FDA has approved Piasky (crovalimab-akkz) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Piasky is a complement C5 inhibitor that blocks the terminal complement pathway. In the Phase 3 COMMODORE 2 trial, Piasky demonstrated non-inferiority to eculizumab in controlling hemolysis and preventing breakthrough hemolysis. The subcutaneous administration of Piasky every 4 weeks offers a more convenient dosing option compared to intravenous eculizumab every 2 weeks. This approval provides patients with PNH a new treatment option with a more convenient administration schedule.