Drug intelligence / Profile preview

human normal immunoglobulin (Kedrion Biopharma)

Development stage
Unknown
Lead developer
Kedrion
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Kedrion SCIg is a 16% subcutaneous human normal immunoglobulin (SCIg) preparation developed by Kedrion Biopharma for the treatment of primary and secondary immunodeficiency disorders. As a plasma-derived biologic, it consists of highly purified immunoglobulin G (IgG) antibodies harvested from human plasma pools. The therapy is designed to provide passive immunity by replacing deficient or absent endogenous IgG, thereby preventing recurrent bacterial and viral infections in patients with hypogammaglobulinaemia or agammaglobulinaemia. The 16% concentration allows for the administration of high doses in smaller volumes compared to lower-concentration formulations, facilitating subcutaneous delivery. It has been evaluated in Phase II/III clinical trials in Italy, demonstrating efficacy, safety, and tolerability as a replacement therapy.

Other names
Kedrion SCIg16% subcutaneous human normal immunoglobulinKedrion 16% SCIghuman normal immunoglobulin 16%
02

Targets

FCGRT (Neonatal crystallizable fragment receptor)C1Q (Complement C1q)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)

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