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.
Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients
Some seven weeks after announcing top-line data, Novartis is unveiling more details on its momentum-building rare disease drug, iptacopan, specifically a head-to-head phase 3 victory against AstraZeneca’s anti-C5 competition. And the Big Pharma is emphasizing the drug’s benefit as a standalone therapy as it expands development.