FDA approves C5 inhibitor for paroxysmal nocturnal hemoglobinuria

Crovalimab-akkz (PiaSky) is a complement C5 inhibitor indicated for the treatment of paroxysmal nocturnal hemoglobinuria in adult and pediatric patients ≥13 years of age and weighing ≥40 kg. Efficacy was evaluated in the phase 3 COMMODORE-2 trial (N=204) in which crovalimab was found to be noninferior to eculizumab, the current standard of care. The recommended dosage regimen consists of one IV loading dose, followed by four additional weekly loading doses given by SC injection. The maintenance dose is then given q4wks by SC injection.