FDA Grants Full Approval to Novartis' Fabhalta (iptacopan) for IgA Nephropathy
FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
On Friday, the U.S. Food and Drug Administration (FDA) granted traditional approval for Novartis AG’s oral medication, Fabhalta (iptacopan). The treatment is authorized to slow the decline of kidney function in adult patients suffering from primary immunoglobulin A nephropathy (IgAN) who face a high risk of disease progression. The approval makes Fabhalta the first and only complement inhibitor shown to significantly slow kidney function decline in adults with primary IgAN at risk of disease progression.
Fabhalta, recognized as a first-in-class complement inhibitor, secured this traditional approval following a priority review. It previously obtained accelerated FDA approval in August 2024 for reducing proteinuria in primary IgAN patients. The FDA based its decision on results from the Phase 3 APPLAUSE-IgAN clinical trial. Final 24-month data from the APPLAUSE-IgAN study were published in The New England Journal of Medicine in March. The study showed Fabhalta slowed the decline in estimated glomerular filtration rate (eGFR) by 48% compared to placebo over two years. Specifically, patients treated with Fabhalta demonstrated an annualized mean eGFR decline of just -3.0 mL/min/1.73 m²/yr, compared to a steeper decline of -5.7 mL/min/1.73 m²/yr in the placebo group. Patients also experienced clinically meaningful reductions in proteinuria as early as two weeks into treatment.
IgAN is one of the most common autoimmune kidney diseases globally, with approximately 25 people per million newly diagnosed each year, and up to half of patients with persistent proteinuria progress to kidney failure within 10 to 20 years, often requiring dialysis or transplantation. Because IgAN can progress to kidney failure requiring dialysis or a transplant, slowing kidney function decline with Fabhalta could help delay the need for those interventions in at-risk patients.
Fabhalta maintained a favorable safety profile consistent with prior data, with the most common adverse events being abdominal pain, dizziness, and nausea. Due to the potential risk of severe infections from encapsulated bacteria, the drug is dispensed exclusively through a Risk Evaluation and Mitigation Strategy (REMS) program, which mandates proper vaccinations before initiating therapy.
Fabhalta was first approved by the FDA in December 2023 for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. In March 2025, it gained approval for complement 3 glomerulopathy (C3G), becoming the first treatment approved for that condition, alongside approvals in China and Japan, and it also received European Commission approval in 2025.
Days before the full approval, the FDA also cleared Vera Therapeutics’ atacicept—now branded as Trutakna—for IgAN. The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. Povetacicept is a fusion protein therapeutic that works by inhibiting both BAFF and APRIL cytokines. In March, topline Phase 3 data showed a 49.8% decrease in urine protein creatinine ratio (UPCR) at 36 weeks in patients on povetacicept versus placebo. Novartis’ Fabhalta elicited a 44% UPCR reduction in APPLAUSE-IgAN, leading to its accelerated approval.
Commercially, Fabhalta generated USD 169 million in sales during the first quarter of 2026, more than doubling the USD 81 million recorded in the same period a year earlier (103% at constant currency). Novartis also noted that nearly all eligible U.S. patients can access Fabhalta for $10 or less monthly through support programs. The company continues to broaden its IgAN pipeline, which also features Vanrafia (atrasentan) and the investigational drug zigakibart.