According to Novartis, the APPLAUSE-IgAN trial of Fabhalta is the first and only phase 3 study to demonstrate significant proteinuria (protein in urine) reduction by targeting the complement system in patients with IgAN, a rare kidney disease that can progress to kidney failure within 10 years.
Results from a pre-specified interim analysis demonstrated that patients treated with Fabhalta achieved a 38.3% proteinuria reduction at 9 months when compared to placebo on top of supportive care.
If approved in IgAN, Fabhalta would be the first treatment that specifically targets the alternative complement pathway.
The standard of care for PNH, C5 inhibitorC5 inhibitor treatments administered as infusions, may leave symptoms, including hemolysis, bone marrow failure and thrombosis, uncontrolled. While over one-third of patients on anti-C5 treatments require blood transfusions at least once per year, in Novartis' phase 3 APPLY-PNH trial, nearly all patients treated with Fabhalta did not receive blood transfusions.
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