Drug intelligence / Profile preview

human normal immunoglobulin (Octapharma)

Development stage
Approved
Lead developer
Octapharma
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

NGAM-11 is a Phase III clinical trial protocol identifier used by Octapharma to evaluate the safety and efficacy of different dose regimens of Panzyga (human normal immunoglobulin, 10% liquid preparation) in pediatric patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Panzyga is an intravenous immunoglobulin (IVIg) therapy derived from pooled human plasma that contains a broad spectrum of immunoglobulin G (IgG) antibodies. It acts as an immunomodulatory agent, helping to suppress the aberrant autoimmune response that attacks the myelin sheath of peripheral nerves in CIDP patients. Panzyga is already FDA-approved for adult CIDP, primary humoral immunodeficiency (PI), and chronic immune thrombocytopenia (cITP).

Brand names
Panzyga
Other names
human normal immunoglobulin Gimmune globulin intravenous (human)immunoglobulin Gintravenous immunoglobulin
02

Targets

NeuraminidaseFcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)

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