Novartis on Monday reported positive results from a Phase III study of Fabhalta (iptacopan) in C3-deposit glomerulonephritis (C3G), an orphan kidney disease.

In a press release, the Swiss biopharmaceutical group said the trial showed a "clinically notable and statistically significant" 35.1% reduction in proteinuria versus placebo over six months.

In addition, the trial was marked by a +2.2 mL/min/1.73 m2 improvement in glomerular filtration rate (GFR), a measure of renal function, compared with placebo.

Following these good results, presented at the European Renal Association (ERA) congress, Novartis plans to file for registration in C3-deposited glomerulonephritis in Europe and the US in the second half of 2024.

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