Likelihood of Approval and Phase Transition Success Rate Model – Immune Globulin (Human) in Coronavirus Disease 2019 (COVID-19)
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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Immune Globulin (Human) in Coronavirus Disease 2019 (COVID-19) Drug Details:
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, primary immune deficiency 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, immune-mediated necrotizing myopathy and Alzheimer’s disease.
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
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