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Novartis Looks To File Fabhalta By Year-End For C3G

 
• By Alaric DeArment

The company presented positive Phase III data at the American Society of Nephrology meeting for the factor B inhibitor in C3G, a rare kidney disease with no approved treatments.

Novartis

Novartis AG is looking to add a third indication to the label of Fabhalta (iptacopan) on the back of Phase III data in C3 glomerulopathy (C3G), a disease that has no US Food and Drug Administration-approved treatments.

Novartis presented data on 26 October at the American Society of Nephrology (ASN) meeting from the APPEAR-C3G trial, which enrolled 74 patients randomized either to Fabhalta (n=38) or placebo (n=36)

Key Takeaways
  • Novartis presented positive 12-month data from the APPEAR-C3G trial of Fabhalta at the 2024 ASN meeting.
  • The data showed efficacy both at the six-month mark and among patients in the placebo arm who switched to Fabhalta, which has a more direct mechanism of action in C3G than in the approved IgAN indication

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