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NewGam
NewGam is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses.
NewGam is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).
At a glance
| Generic name | NewGam |
|---|---|
| Also known as | Human normal immunoglobulin, Panzyga |
| Sponsor | Octapharma |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Multiple (polyspecific human immunoglobulins; Fc receptors and complement) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
NewGam functions as a replacement or supplementation therapy for patients with immunodeficiency or as an immunomodulatory agent in autoimmune and inflammatory conditions. The pooled immunoglobulins bind to pathogens and aberrant immune targets, facilitating their clearance and dampening pathogenic immune responses. It is derived from human plasma and contains a broad spectrum of antibodies against common infectious agents and self-antigens.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion reactions
- Thrombosis (rare)
Key clinical trials
- Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment (PHASE2)
- Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy (PHASE3)
- Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia (PHASE3)
- High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) (PHASE3)
- A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases (PHASE3)
- Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |