Novartis reports positive results from a pre-specified interim analysis of the phase III APPLAUSE-IgAN study of Fabhalta (iptacopan), in patients with IgA nephropathy (IgAN), a major cause of chronic kidney disease worldwide.

In the analysis, patients treated with Fabhalta achieved a clinically and statistically significant 38.3% reduction in proteinuria at nine months, compared with placebo plus supportive care.

The primary endpoint, assessing Fabhalta's ability to slow IgAN progression by measuring the annualized slope of total glomerular filtration rate (eGFR) over 24 months, is expected at the end of the study in 2025.

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