Credit: Novartis. The approval was based on data from the phase 3 APPLY-PNH trial. Health care providers who prescribe Fabhalta must enroll in the Fabhalta REMS. The Food and Drug Administration (FDA) ...
Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement ...
Iptacopan treatment on top of standard of care resulted in significant and clinically meaningful reductions in proteinuria compared with placebo in patients with complement 3 glomerulopathy. Results ...
Iptacopan is the first FDA-approved treatment for C3G, targeting the disease's underlying cause by inhibiting the alternative complement pathway. The phase 3 APPEAR-C3G study showed a 35.1% reduction ...
Persistent hemolytic anemia and a lack of oral treatments are challenges for patients with paroxysmal nocturnal hemoglobinuria who have received anti-C5 therapy or have not received complement ...
The alternative complement pathway plays a key role in the pathogenesis of IgA nephropathy. Iptacopan specifically binds to factor B and inhibits the alternative pathway. In this phase 3, double-blind ...
Basel, December 8, 2022 — Novartis today announced the Phase III APPOINT-PNH study (NCT04820530) of investigational oral monotherapy iptacopan in complement-inhibitor-naïve (including anti-C5 ...
Novartis (NYSE:NVS) reported detailed results from a phase 3 trial of its oral drug iptacopan to treat certain patients with paroxysmal nocturnal hemoglobinuria (PNH). The study, dubbed APPOINT-PNH, ...
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