Novartis' Iptacopan for C3 Glomerulopathy Files for Approval in China, Marking a Global First

On September 5, the CDE website showed that Novartis' third indication for Iptacopan has been submitted for marketing approval.Application No.: JXHS2400061）According to the Insight database, the indication is likely C3 glomerulopathy (C3G）。Notably, outside of China, no marketing application for this indication has been submitted in any other countries.

Screenshot from:CDE Official Website

Iptacopan is an oral CFB inhibitor under research by Novartis.In April this year, Eptacog alfa was approved for the first time in China, for use in adults.Paroxysmal Nocturnal Hemoglobinuria（PNH）Patient Treatment.

On May 25 this year,Novartis announcedEptinezumab TreatmentLatest Phase III Data on C3 Glomerulopathy（APPEAR-C3G，NCT04817618）。In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, adult patients were randomly assigned in a 1:1 ratio to receive either eptacog alfa or placebo on top of supportive care, followed by a 6-month open-label period.

The results showed that, compared with placebo,Patients treated with Ipkapan at 6 months had proteinuria (Through 24-hour UPCR) decreased by 35.1% (p=0.0014）, the results are clinically and statistically significant. Secondary endpoint eGFR data indicate a numerical improvement over placebo during the 6-month period.

Screenshot from:Insight Database

According to the Insight database,CurrentlyIpsen has been approved globally for two indications, respectivelyParoxysmal Nocturnal Hemoglobinuria andIgA Nephropathy, among which,Paroxysmal nocturnal hemoglobinuria has been approved in China, IgA nephropathy was also reported for marketing in China on August 7 this year.The application submitted in China this timeC3 Glomerulopathy is the first in the world to be reported for marketing in China, leading globally in progress.

Screenshot source: Insight Database

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