Novartis: presents positive results for Fabhalta
(CercleFinance.com) - Novartis today presented 12-month data from the APPEAR-C3G phase III study at the American Society of Nephrology (ASN) Kidney Week 2024.
These data show that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta (iptacopan) in addition to supportive care achieved clinically significant and durable results at one year.
These data confirm that treatment with Fabhalta resulted in a clinically significant reduction in proteinuria, which was observed as early as day 14 and was maintained at 12 months.
Similarly, during an open-label period of the study, a reduction in proteinuria was observed in participants who switched to Fabhalta.
The APPEAR-C3G study evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G.
The study included a 6-month randomized double-blind treatment period with Fabhalta versus placebo, followed by an additional 6-month open-label treatment period during which all participants received Fabhalta.
Results previously presented at the European Renal Association (ERA) Congress 2024 demonstrated a statistically significant and clinically meaningful reduction in proteinuria of 35.1% versus placebo in addition to supportive care at 6 months.
' As a clinician treating young people with C3G, I see first-hand the challenges posed by the therapies used today to treat this disease, underscoring the vital need for dedicated treatment for these patients', said Carla Nester, MD, MSA, FASN, Professor of Pediatrics-Nephrology at the University of Iowa and co-investigator of the APPEAR-C3G study.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
These data show that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta (iptacopan) in addition to supportive care achieved clinically significant and durable results at one year.
These data confirm that treatment with Fabhalta resulted in a clinically significant reduction in proteinuria, which was observed as early as day 14 and was maintained at 12 months.
Similarly, during an open-label period of the study, a reduction in proteinuria was observed in participants who switched to Fabhalta.
The APPEAR-C3G study evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G.
The study included a 6-month randomized double-blind treatment period with Fabhalta versus placebo, followed by an additional 6-month open-label treatment period during which all participants received Fabhalta.
Results previously presented at the European Renal Association (ERA) Congress 2024 demonstrated a statistically significant and clinically meaningful reduction in proteinuria of 35.1% versus placebo in addition to supportive care at 6 months.
' As a clinician treating young people with C3G, I see first-hand the challenges posed by the therapies used today to treat this disease, underscoring the vital need for dedicated treatment for these patients', said Carla Nester, MD, MSA, FASN, Professor of Pediatrics-Nephrology at the University of Iowa and co-investigator of the APPEAR-C3G study.
Copyright (c) 2024 CercleFinance.com. All rights reserved.