Fabhalta® is the official global commercial brand name, and Feiheda is its Chinese brand name developed by Novartis. It is an oral proximal complement factor B inhibitor. It targets complement factor B of the alternative complement pathway, blocks abnormal complement‑mediated activation, reduces complement‑driven cell damage and inflammatory injury.
Main Indications
Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy;
Reduction of proteinuria in adult patients with primary IgA nephropathy at risk of rapid disease progression;
Treatment of adult patients with C3 glomerulopathy (C3G) for proteinuria reduction.
Clinical Research
Global multicenter phase III pivotal trials demonstrated that iptacopan effectively controls intravascular hemolysis and stabilizes hemoglobin levels in PNH patients without prior complement‑inhibitor treatment;
Phase III clinical studies for IgA nephropathy confirmed that iptacopan achieves substantial proteinuria reduction and slows renal function decline in high‑risk adult subjects;
Clinical trials including Chinese patients demonstrated efficacy and safety profiles consistent with global study populations;
Long‑term extension studies verified sustained therapeutic benefits during continuous oral administration.
Common Side Effects
Gastrointestinal adverse events: nausea, diarrhoea, abdominal pain;
Increased risk of serious Neisseria infections including meningococcal infection (rare but severe);
Common mild adverse reactions: headache, dizziness, upper‑respiratory‑tract infection, nasopharyngitis, elevated blood creatine kinase.
Approval Status in China
Original drug Fabhalta® (Iptacopan Hydrochloride Capsules) was officially approved for marketing in China in April 2024, with the specification of 200 mg per capsule. It has been included in China’s national medical insurance catalogue.
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