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
Click here to read full press release/ article | Ref: Globe Newswire | Image: BioSpace
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