KIg10

**KIg10** is a novel 10% intravenous immunoglobulin (IVIG) formulation developed by Kedrion for the replacement therapy in patients with primary immunodeficiency diseases (PID), including common variable immunodeficiency (CVID). It provides pooled human IgG antibodies to prevent infections by supplementing deficient humoral immunity, administered at doses of 200-800 mg/kg every 21 or 28 days. Phase 3 trials (e.g., NCT03961009, NCT04944979) in adults and pediatrics demonstrated no acute serious bacterial infections (rate <1 per patient-year per FDA guidance), maintained protective antibody levels (anti-tetanus, pneumococcal, measles, H. influenzae b), comparable pharmacokinetics to approved IVIGs (e.g., Cmax ~1200-1500 mg/dL, half-life consistent), and good tolerability with mostly mild infusion-related AEs like headache (12.4% of infusions). Ongoing studies explore Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Immune Thrombocytopenia (ITP).[1][2][4][5][7][8]

Brand names

Yimmugo

Other names

Kedrion IVIg 10%Kedrion Immunoglobulin 10%Intravenous Human Normal Immunoglobulin 10%Intravenous Human Immune Globulin 10%