GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 post-COVID postural orthostatic tachycardia syndrome, primary immune deficiency, dermatomyositis, diffuse cutaneous systemic sclerosis (subcutaneous formulation), 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 and chronic lymphocytic leukemia (CLL). It was also under development for the treatment of Guillain-Barre syndrome and diffuse cutaneous systemic sclerosis (intravenous formulation), autoimmune epilepsy, acute traumatic spinal cord injury and immune-mediated necrotizing myopathy.

CSL overview

CSL is a biotechnology company. It discovers, develops, manufactures, commercializes and distributes biopharmaceuticals. The company’s product portfolio comprises treatments for hemophilia and immune deficiency, vaccines to prevent influenza and therapies for iron deficiency and kidney conditions. CSL‘s proprietary platform consists of plasma and recombinant protein technology, cell and gene therapy and adjuvant cell-based egg-based mRNA. CSL focuses on conditions related to hematology, respiratory, cardiovascular and metabolic, nephrology and transplant, immunology and vaccines, among others. The company operates in various countries including Australia, China, Germany, Switzerland, the US, Hungary, Puerto Rico, the UK, Italy, Japan, the Netherlands and Spain. CSL is headquartered in Melbourne, Victoria, Australia.

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.