The first horse bearing Novartis’ IgAN treatment has reached the FDA’s approval milestone. FABHALTA is approved for use in treating IgAN patients who are at risk of swift disease progression, as evidenced by a urine protein-to-creatinine ratio of 1.5 g/g or higher.
On August 8, the FDA approved the use of Novartis’ complement inhibitor FABHALTA (iptacopan) to reduce proteinuria in patients with primary IgA nephropathy. This approval represents the first regulatory success for a complement inhibitor for this condition.
Novartis is developing three drugs for a rare autoimmune kidney disease: a complement factor B inhibitor, the endothelin A receptor antagoni...
