Novartis has released pre-specified interim analysis data from the P-III (APPLAUSE-IgAN) trial to investigate Fabhalta’s (200mg, oral, BID) safety & efficacy vs PBO to treat primary IgAN adults (n=518). The analysis evaluated 250 participants for efficacy & 443 for safety
The analysis demonstrated a 38.3% reduction in proteinuria at 9mos. vs PBO alongside supportive care. The 1EP of slowing IgAN progression, estimated by annualized total eGFR slope at 24mos. is anticipated during trial completion in 2025
The safety of the drug was well-tolerated and favorable, aligning with the prior studies. These results plus IgAN & C3 glomerulopathy (C3G) real-world studies were highlighted at WCN
Ref: Novartis | Image: Novartis
Related News:- Novartis Reports US FDA’s Approval of Fabhalta (iptacopan) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
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