FDA Approves PiaSky for the Treatment of Paroxysmal Nocturnal Hemoglobinuria
The U.S. Food and Drug Administration (FDA) approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
- Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood condition in which
red blood cells are destroyed by the body’s complement system (part of the innate immune
system). This causes symptoms such as anemia, fatigue, and blood clots, and can lead to kidney
disease. - PiaSky contains crovalimab-akkz which is a C5 inhibitor that is recycled within the bloodstream,
enabling sustained complement inhibition through low-dose administration every four weeks. - PiaSky is administered as a single loading dose by intravenous infusion on Day 1, followed by four
additional weekly loading doses administered by subcutaneous injection on Days 2, 8, 15, and 22.
Maintenance dosing starts on Day 29 and is administered every 4 weeks by subcutaneous injection.
