Novartis Reports Positive Results of Iptacopan in P-III (APPEAR-C3G) for the Treatment of C3 glomerulopathy (C3G)
Shots:
- The P-III (APPEAR-C3G) study evaluating safety & efficacy of iptacopan (200mg; BID) vs PBO for the treatment of patients (n=83) with C3G). The 1Ep of the study includes proteinuria reduction at 12 mos. & a comparison between proteinuria reduction at 6 &12 mos.
- The study demonstrated a reduction in proteinuria at 6 mos. measured by UPCR. The 2EPs include evaluation of changes in eGFR, the proportion meeting composite renal criteria, glomerular inflammation, patient-reported fatigue, safety & tolerability
- Furthermore, a separate group of adolescent patients with C3G is currently being enrolled. Based on P-II data Iptacopan has been granted FDA BTD, as well as ODD from both the FDA & EMA for C3G & PNH. It has also received EMA PRIME designation for C3G and ODD for IgAN
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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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
