Novartis' First-in-Class Oral Factor B Inhibitor Iptacopan Receives New NMPA Approval for Primary IgA Nephropathy in China
Novartis
Drug Development and Manufacturing
August 2024,Iptacopan Receives New Indication Approval in the US for IgA Nephropathy. The approval is based on positive results from the interim analysis of the Phase III APPLAUSE-IgAN study.
This isA multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III study, with China participating in global synchronized development, aiming to evaluateOral twice dailyIpsen（200mg）Efficacy and safety in 443 adult patients with primary IgA nephropathy.
The primary endpoint isBy measuring 24-hour urine collection samplesUrine Protein/Creatinine Ratio（UPCR）, proving that the drug at 9 monthsReduce ProteinuriaSuperior to placebo in terms of aspects, and based on the data within 24 months.Annualized Total eGFR SlopeReduce measurement results, proving that the drug inSlow the Progression of Kidney DiseaseSuperiority over placebo.
At the 2024 World Congress of Nephrology（WCN）At the conference, Novartis announced the results of this Phase III study.The results showed that, compared with the placebo, patients receiving eptacog beta treatment at 9 monthsProteinuria significantly reduced by 38.3%(ByUPCR Measurement)。
Apart from the approved indications,EpicopanAlso under development are a series of other rare diseases, includingAtypical Hemolytic Uremic Syndrome, Membranoproliferative Glomerulonephritis, and Lupus Nephritisetc.
