Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior hemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy1-5
If approved, Fabhalta® will be the first oral monotherapy available in Europe for the treatment of PNH, a chronic and rare blood disorder, in both complement inhibitor-treated and -naive PNH patients with hemolytic anemia1
Despite anti-C5 therapy, a large proportion of patients remain anemic, fatigued