Findings from the APPEAR-C3G trial showed a 35% reduction in 24-hour UPCR from baseline (primary endpoint) in the iptacopan group compared with the placebo group. The Food and Drug Administration ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

The results from the phase 3 APPEAR-C3G study showed that Fabhalta (iptacopan) met its primary objective of an improvement of protein in the urine (proteinuria) compared to placebo at six months ...

Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to support the FDA’s recent approval of iptacopan (Fabhalta; Novartis ...

The indications are C3 glomerulopathy (C3G) and primary immune complex membranoproliferative ... market for kidney disease treatments. NVS’ Fabhalta (iptacopan) obtained approval in the United ...

William Blair writes, “We believe the recent approval of Fabhalta (iptacopan) for the treatment of adults with C3G bodes well for an approval of Empaveli given it demonstrated what we believe is ...

A similar filing seeking the label expansion of the drug to treat C3G and IC-MPGN patients is also currently under review in the EU. Swiss pharma giant, Novartis NVS, is also a formidable player in ...

Last month, the regulatory body approved Fabhalta for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. The drug was granted accelerated approval for the indication of ...

Novartis recently announced that the FDA has approved Fabhalta for a third indication, C3G, to reduce proteinuria. Per NVS, this is the first and only treatment approved for this condition.

The eGFR data are expected in 2026 and intended to support traditional FDA approval. (Image Credits: Pixabay) Novartis on Thursday announced the US Food and Drug Administration (FDA) has granted ...