The latest label expansion for Novartis’s Fabhalta (iptacopan), for C3 glomerulopathy (C3G), allows the firm to expand its growing presence in the renal disease space, which the Swiss drug maker will do by employing digital technology and artificial intelligence to reach patients with the rare kidney disease.
The US Food and Drug Administration approved Fabhalta, a complement factor B inhibitor, on 20 March for reducing proteinuria in patients with C3G, which has a relatively small population but no other approved drugs. The new indication adds to Fabhalta’s existing approvals
Key Takeaways
- The FDA approved Novartis’s Fabhalta for C3 glomerulopathy, the third indication for the drug and part of the drug maker’s growing renal disease franchise.
- The approval makes Fabhalta the first approved drug for C3G, a much rarer disease than IgA nephropathy, but one treated by the same nephrologists
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