On April 15, Novartis in ChinaWorld Congress of Nephrology (WCN)Announced the interim analysis results of the Phase III APPLAUSE-IgAN study of Fabhalta (iptacopan) in patients with IgA nephropathy (IgAN).The studyYesOneMulticenter, FollowMachine, Double-blind, Placebo-controlledClinical trial (n=518)）, aimed at evaluatingIpecopan (200mg, oral,Daily2Time）TreatmentPrimaryIgANSuccessPersonThe efficacy and safety of patients.ResearchPrimary EndpointIt was passed in the 9th month.Urinary Protein/Creatinine Ratio (UPCR）AssessmentChanges in Proteinuria LevelsAnd24 monthsWithinAnnualized Total Glomerular Filtration Rate（eGFR）Slope.Main Study PopulationBaselineeGFR≥30mL/min/1.73m2，BaselineUPCR≥1g/g。In addition, a small batchRenal FunctionSevereIncomplete patients (BaselineeGFR：20-30mL/min/1.73m2) has also been included in the research, but notParticipateMainEfficacy Analysis。Efficacy analysis results in 250 patients with IgAN showed that,Compared with the placebo groupIn comparison,Ipcopan GroupPatientOfProteinuria LevelDecreased by 38.3%(p<0.0001). InSafety analysis results from 443 patients with IgAN showed，The Safety of Ipkapan andWell tolerated, consistent with previous studiesConsistent.Based on the positive results of the interim analysis, Novartis has applied to the FDA for accelerated approval.Ipsen is used forA supplemental New Drug Application (sNDA) for the treatment of patients with IgAN has been granted Priority Review by the FDA. If approved, the drug will becomeThe first IgAN therapy specifically targeting the alternative complement pathway.EpicopanDeveloped by NovartisFor Alternative Complement PathwayLu's Complement Factor B (CFB) Inhibitor,Approved by the FDA in December 2023 for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).IgAN is aRareHeterogeneous, progressive kidney disease.It is estimated that approximately 25 people per million are newly diagnosed with IgAN worldwide each year. Up to 30% of IgAN patients with persistent high levels of proteinuria (≥1g/day) may progress to kidney failure within 10 years. Clinically, there is a need for effective targeted therapies for IgAN to slow or prevent the progression to kidney failure.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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