Basel, May 25, 2024 – Novartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® (iptacopan) at the late-breaking clinical trials session of the European Renal Association (ERA) Congress1. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% (p=0.0014) reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 6 months when compared to placebo on top of supportive care1. In many kidney diseases, proteinuria reduction is an increasingly recognized surrogate marker correlating with delaying progression to kidney failure14,15.
Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future medical...
Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said.
APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1IgAN is a heterogeneous, progressive, rare...
Novartis' Fabhalta wins EU panel's favour for rare blood disorder
FABHALTA (iptacopan) Now Available from Onco360 as the First FDA-Approved Oral Monotherapy Approved for the Treatment of Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Novartis shows strong Fabhalta results in another blood disorder
EAST HANOVER, N.J., Dec. 5, 2023 /PRNewswire/ -- Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). In clinical trials, treatment with Fabhalta increased hemoglobin levels (? 2 g/dL from baseline in the absence of RBC transfusions) in the majority of patients and in APPLY-PNH nearly all patients treated with Fabhalta did not receive blood transfusions1-5.
Late-breaking final iDFS analysis from NATALEE investigating Kisqali® (ribociclib) in broad population of patients with stage II and III HR+/HER2- early breast cancer, including those with...
Novartis’ investigational oral factor B inhibitor has hit its early target in a phase 3 kidney disorder trial, a success that has the pharma readying to submit a request for fast-track FDA approval next year.