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Novartis Reports Data from P-III (APPEAR-C3G) Study of Fabhalta (Iptacopan) in C3 Glomerulopathy (C3G)

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Novartis Reports Data from P-III (APPEAR-C3G) Study of Fabhalta (Iptacopan) in C3 Glomerulopathy (C3G)

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  • Novartis presented data at ASN Kidney Week’24 from P-III (APPEAR-C3G) study of Fabhalta (factor B inhibitor) + supportive care to treat adult individuals with C3 glomerulopathy (C3G)
  • P-III (APPEAR-C3G) assessed the safety and efficacy of oral Fabhalta (200mg, BID) vs PBO in C3G adult individuals for 6mons. followed by an additional 6mons. of Fabhalta administration in all incl. PBO receiving individual 
  • The study demonstrated proteinuria reduction as early as 2wks. and maintained at 12mons. with individuals switched to Fabhalta also showed reduction. Additionally, improvement in eGFR slope with a favorable safety profile was observed. US regulatory submission for Fabhalta was expected by the 2024 end

Ref: Novartis | Image: Novartis

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