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Fabhalta gains full FDA approval for proteinuria reduction in IgA nephropathy
The FDA granted full approval to iptacopan to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk for disease progression, according to a company press release. Iptacopan (Fabhalta, Novartis) is a first-in-class factor B complement inhibitor. Based on data from the APPLAUSE-IgAN trial, accelerated approval was granted in August 2024.
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healio.com
Fabhalta gains full FDA approval for proteinuria reduction in IgA nephropathy
The FDA granted full approval to iptacopan to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk for disease progression, according to a…
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medpagetoday.com
First Complement Inhibitor Wins Full Approval in IgA Nephropathy
Iptacopan significantly slowed kidney decline in a phase III trial
