The U.S. Food and Drug Administration recently approved PiaSky (crovalimab) for treating paroxysmal nocturnal hemoglobinuria.
PiaSky is a monthly subcutaneous for PNH, a condition that prematurely breaks down red cells, which can lead to anemia, fatigue, blood clots, and potentially kidney disease. The chronic condition affects around 20,000 people worldwide, according to Roche, the drug manufacturer.
The approval is based on a late-stage study showing that PiaSky controlled the destruction of red blood cells in 79.3% of patients from week 5 to week 25. Other treatments for PNH require infusion by health care professionals.
PiaSky was previously approved in China in February and Japan in March. The drug is also being tested for other conditions, including atypical hemolytic uremic syndrome, sickle cell disease, and lupus nephritis.