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 G (also known as human normal immunoglobulin) (Flebogamma DIF/Gamimune N/Gammaked/ Gamunex C/ Flebogamma/ IGIVnex/ GamaSTAN S/D/ Gamunex/ Igamplia/ Plangamma/ Polyglobin/ GamaSTAN, Plitagamma) is an antibody preparation derived from plasma acts as passive immunizing preparation. It is formulated as solution for intramuscular or subcutaneous route of administration. Flebogamma DIF (Double Inactivation and Filtration) and Gamunex is used for replacement therapy in patients with primary immunodeficiency syndromes with impaired antibody production and for hypogammaglobulinemia in various pathological conditions. They also used for the treatment of primary immune thrombocytopenia (ITP), Guillain Barre syndrome and Kawasaki disease. Gamunex-C [Caprylate/Chromatography Purified] is used for the Primary Humoral Immunodeficiency, Idiopathic Thrombocytopenic Purpura (ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Flebogamma DIF is indicated for the treatment of  chronic immune thrombocytopenia (ITP) in adults and children aged ≥2 years and primary immunodeficiency (PI) in adults. GamaSTAN S/D is prepared by cold ethanol fractionation from human plasma. GamaSTAN S/D and Igamplia is used for the prophylaxis of rubella, measles, varicella and hepatitis A. Flebogamma DIF and Gammunex injection solution are administered via intravenous route of administration. GamaSTAN S/D and Igamplia are administered by intramuscular route of administration.

The drug candidate is also under development for the treatment of Coronavirus disease 2019 (COVID-19), postural tachycardia syndrome, Alzheimer's disease, primary immunedeficiency disease. The drug candidate was also under development for the treatment of cutaneous lupus erythematosus, relapsing remitting multiple sclerosis, epilepsy, myasthenia gravis, stiff-person syndrome and occult choroidal neovascularization.

it was also under development for treatment induced neuropathy of diabetes and post-polio syndrome and immune-mediated necrotizing myopathy.

Grifols overview

Grifols develops, produces, and markets plasma-derived medicines and transfusion medicines. The company is focused on research, development, manufacturing and marketing of plasma-derived therapies, hospital pharmacy products and diagnostic technology for clinical use. It produces plasma derived protein therapies for patients suffering from rare, chronic and life-threatening infections. The company’s major products include essential plasma-derived medicines for treating conditions across various therapeutic areas such as neurology, immunology, hepatology, intensive care, pulmonology, hematology, and infectious diseases. Grifols provides transfusion medicine, hemostasis and immunoassay solutions for blood banks, clinical laboratories and transfusion centers. The company offers its products to hospitals, pharmacies and healthcare professionals. It offers products in the US, Canada, Europe, and Rest of the world. Grifols is headquartered in Barcelona, Spain.

For a complete picture of Immune globulin (human)’s drug-specific PTSR and LoA scores, buy the report here.

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.