The injection Ultomirus (ravulizumab) has been approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris is a long-acting complement inhibitor that prevents hemolysis. Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research says, “Ultomiris uses a novel formulation so patients only need treatment every eight weeks, without compromising efficacy.” This beats the previous therapy that was required every two weeks.
Read the full FDA press release here.
Read prescribing information online here.