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 ...

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).

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 ...

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 ...

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice ...

Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for the ultra-rare kidney disease complement 3 glomerulopathy (C3G). Every ...

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 ...

have recommended reimbursement of Fabhalta in the treatment of adult patients with PNH who have an inadequate response to, or are intolerant of, a C5 inhibitor 5,6 Novartis Pharmaceuticals Canada ...

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

MONTREAL, April 14, 2025 /CNW/ - Novartis Canada is pleased to announce that Fabhalta ® (iptacopan capsules) is now available across Canada for adult patients with paroxysmal nocturnal ...