Shots:

• The accelerated approval was based on P-III (APPLAUSE-IgAN) study assessing the safety & efficacy of Fabhalta (200mg, oral, BID) vs PBO to treat primary IgAN patients (n=518). Full approval depends on the trial further evaluating its impact on slowing disease progression through eGFR decline at 24mos., with final data expected in 2025
• Pre-specified interim analysis at 9mos. showed proteinuria reduction of 44% vs 9%, depicting a significant 38% reduction vs PBO. The effect was similar in all the subgroups, with Fabhalta maintaining a favorable safety profile
• Novartis is also investigating atrasentan (endothelin A receptor antagonist, oral) and zigakibart (anti-APRIL mAb, SC), under P-III, for treating IgAN