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immune globulin intravenous (human)
- Development stage
- Approved
- Lead developer
- Kedrion
- Administration
- Intravenous
01
Overview
QIVIGY is a 10% liquid intravenous immune globulin (IVIG) therapy developed by Kedrion Biopharma for the treatment of primary humoral immunodeficiency (PI) in adults. As a highly purified preparation of human immunoglobulin G (IgG) derived from pooled human plasma, it functions by providing passive immunity through the replacement of deficient antibodies. The therapy was approved by the FDA following a 12-month Phase III clinical study that met its primary endpoint of preventing acute serious bacterial infections. QIVIGY represents Kedrion's first internally developed product and is supported by significant investment in U.S. plasma collection and manufacturing infrastructure at its Melville, NY facility.
- Brand names
- QIVIGY
- Other names
- Kedrion IVIG 10%Kedrion Immunoglobulin 10%
02
Targets
FCGR3B (Low affinity immunoglobulin gamma Fc region receptor III-B)FCGR2B (Fc gamma receptor IIB)C1Q (Complement C1q)FCGRT (Neonatal crystallizable fragment receptor)FCGR1A (High affinity immunoglobulin gamma fc receptor I)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)FCGR2A (Low affinity immunoglobulin gamma Fc receptor II-a)
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