New Phase III data on Novartis’ Fabhalta preps drug for new indication

16 April 2024

Having recently gained US regulatory approval for its Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), Swiss pharma giant Novartis (NOVN: VX) is now arming itself with clinical data for a new indication.

Novartis today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta in patients with IgA nephropathy (IgAN). In the analysis, patients treated with Fabhalta achieved a 38.3% (p<0.0001) proteinuria reduction (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at nine months when compared to placebo on top of supportive care.

The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data. Results were presented today during a late-breaking clinical trials session at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina1.

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