Phase III Success! Novartis Oral Drug Fabhalta® Significantly Slows Progression of IgA Nephropathy

On October 16, 2025, Novartis announced that its oral complement pathway inhibitor Fabhalta® (iptacopan) showed positive results in a Phase III clinical study targeting adult patients with IgA nephropathy (IgAN).APPLAUSE-IgANAchieved positive final results in China.

Research shows that, compared with placebo, Fabhalta significantly slowed the decline of estimated glomerular filtration rate (eGFR) over a two-year treatment period.The results are statistically and clinically significant, indicating that the drug is effective in delaying renal function decline.

Fabhalta is an oral factor B inhibitor that acts on the alternative pathway of the complement system.The drug received accelerated approval from the U.S. Food and Drug Administration (FDA) as early as 2024., used to reduce proteinuria in adult patients with IgA nephropathy.

The approval was based on the interim analysis results of APPLAUSE-IgAN, which showed that Fabhalta significantly reduced the urine protein-to-creatinine ratio (UPCR) within 9 months, with a reduction notably superior to that of the placebo group.This final analysis further confirms that Fabhalta not only reduces proteinuria but also slows kidney function decline, reinforcing its long-term benefit potential in IgAN treatment.

In terms of safety, Fabhalta demonstratedGood tolerability, safety profile consistent with previous data, no new safety risks observedNovartis stated that it will release more detailed study data, including results of the composite endpoint of renal failure and other secondary endpoints, at upcoming medical conferences.

Novartis plans to use the research data to submit a formal approval application for Fabhalta to global regulatory authorities in 2026, making itThe First Oral Targeted Complement Inhibitor that Can Simultaneously Reduce Proteinuria and Slow the Progression of Kidney Function Deterioration. This achievement not only brings new hope to patients with IgAN but also further validates the potential of complement pathway inhibition in the treatment of chronic kidney disease.

Fabhalta was initially approved in 2023 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and has since gained approvals or entered late-stage development for various complement-mediated diseases, including C3 glomerulopathy.

With its milestone progress in the IgAN field, Fabhalta is expected to become a representative drug for precision treatment of complement system diseases, bringing substantial clinical benefits to more patients.

IgA Nephropathy: A Progressive Autoimmune Kidney Disease

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