FDA Approves Roche's PiaSky for PNH Treatment

The U.S. FDA has approved Roche's drug crovalimab, marketed as PiaSky, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a chronic blood disorder. PNH causes the premature breakdown of red blood cells, leading to anaemia, fatigue, and other complications like blood clots and kidney disease. Roche reported that approximately 20,000 individuals worldwide are affected by PNH. The approval is based on a late-stage study demonstrating PiaSky's efficacy in controlling red blood cell destruction, showing a 79.3% reduction compared to the standard-of-care eculizumab. PiaSky offers a less frequent dosing schedule of up to once every four weeks, potentially reducing the need for clinic visits.