▎WuXiEdited by Kant Content Team

Novartis recently presented the 12-month data from the Phase 3 APPEAR-C3G study at the 2024 American Society of Nephrology (ASN) Kidney Week meeting. The results showed that patients with C3 glomerulopathy (C3G) who received oral Fabhalta (iptacopan) treatment on top of supportive care experienced a sustained reduction in proteinuria at 12 months. According to the press release,Fabhalta may become the first drug approved by the U.S. FDA for the treatment of C3G.Novartis has completed the regulatory submission for Fabhalta in the EU, China, and Japan for the treatment of C3G.And is expected to submit a regulatory application to the U.S. FDA by the end of the year.

Data shows,As early as 14 days into the treatment, Fabhalta was observed to reduce proteinuria in patients with C3G, a result that is clinically significant and persisted for up to 12 months.During the open-label phase of the study, subjects who switched to Fabhalta also showed a reduction in proteinuria.Moreover, according to the results of pre-specified exploratory analyses, compared with patients' prior rapid decline in estimated glomerular filtration rate (eGFR),The eGFR slope of the patient improved after receiving Fabhalta treatment.Fabhalta also demonstrated good safety characteristics, and no new safety signals were observed.

Results presented at this year's European Renal Association (ERA) Congress indicated that, on the basis of supportive care, Fabhalta showed advantages compared to placebo,At 6 months, it can statistically significantly reduce patients' proteinuria by 35.1%, which is clinically meaningful.

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References:

[1] Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial. Retrieved https://www.globenewswire.com/news-release/2024/10/26/2969709/0/en/Novartis-oral-Fabhalta-iptacopan-sustained-clinically-meaningful-results-at-one-year-in-Phase-III-C3-glomerulopathy-C3G-trial.html

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