Shots:

• The P-II study involves evaluating the iptacopan vs PBO in 112 patients with IgAN. The new interim results of the P- II study in C3G will also be presented at ERA-EDTA Congress
• The study met its 1EP i.e @ 90days- reduction in proteinuria as measured by 24hrs. UPCR- 23% reduction in proteinuria at the highest dose (200mg- bid)- stabilized renal function as assessed by eGFR. The therapy showed favorable safety & tolerability profile
• The P-III APPLAUSE trial is underway whereas the company plans to initiate P-III studies in other renal indications. The therapy has received EMA’s ODD in IgAN- ODD from the FDA & EMA in C3G & PNH- FDA’s BTD in PNH & EMA’s PRIME designation for C3G

  Ref: Globe Newswire | Image: Novartis