Immune globulin (human) is under clinical development by CSL and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Immune globulin (human)’s likelihood of approval (LoA) and phase transition for Dermatomyositis took place on 08 Feb 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Immune globulin (human) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Immune globulin (human) overview

Human immunoglobulin (Privigen / Hizentra / Beriglobin / Beriglobina P / Beriglobin P / Sandoglobuline / Vivaglobin / Intragam / Privigen AU / Hizentra AU / Evogam / Carimune NF / Sandoglobulin / Behrigamma / Sandoglobulin NF / Armoglobulina P / Gama Venina / Venimmuna N ) is a liquid formulation of human immunoglobulin (Ig). It is formulated as Privigen injectable solution for intravenous administration, Carimune NF lyophilized powder for solution for intravenous administration and as Hizentra injectable solution for subcutaneous administration. Hizentra is indicated for the treatment of primary immunodeficiency (PI). Privigen is used for treatment of primary humoral immunodeficiency and chronic immune thrombocytopenic purpura Privigen is purified from the pooled plasma of thousands of healthy donors, so it contains a wide variety of the antibody specificities and idiotypes available in the general human population. It is also indicated for the treatment of Hypogammaglobulinaemia. This allows Privigen to be used for the treatment of immune disorders requiring immunoglobulin replacement. It acts by suppling opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic and mycoplasma agents and their toxins. Privigen is also indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability, and for the treatment of hypogammaglobulinemia and agammaglobulinemia.

The drug candidate  is under development for the treatment of primary immune deficiency, autoimmune epilepsy, dermatomyositis, acute traumatic spinal cord injury, diffuse cutaneous systemic sclerosis (subcutaneous formulation), immune-mediated necrotizing myopathy, idiopathic inflammatory myopathies and primary immunodeficiency syndromes with impaired antibody production and secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of less than 4 g/l. It was also under development for the treatment of Guillain-Barre syndrome and diffuse cutaneous systemic sclerosis (intravenous formulation).

CSL overview

CSL discovers, develops, manufactures, commercializes and distributes biopharmaceuticals and related products. Its portfolio encompasses plasma-derived products for the treatment of hemophilia, hereditary angioedema, von Willebrand disease, inherited primary and secondary immune deficiencies, respiratory disease, neurological disorders and protein-based medicines for treating serious human illnesses. The company also provides products for the prevention of hemolytic disease in newborns, infection in solid organ transplant recipients and to treat specific infections for victims of trauma and burns. CSL markets an array of vaccines, anti-venoms and pharmaceutical products of various other manufacturers. The company sells its products in Australia, Germany, Switzerland, the US, the UK and other countries. CSL is headquartered in Parkville, Victoria, Australia.

Quick View Immune globulin (human) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Immune globulin (human)
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
  • Oncology
Key Developers
  • Sponsor Company: CSL
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.