Likelihood of Approval and Phase Transition Success Rate Model – Emapalumab in Cytopenia
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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.


Emapalumab in Cytopenia Drug Details:
Emapalumab (Gamifant) is a monoclonal antibody, acts as an immunosuppressant. It is formulated as injectable solution for intravenous route of administration. Gamifant is indicated for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional hemophagocytic lymphohistiocytosis therapy in pediatric (new born and older) and adult patients.Emapalumab (NI-0501, Gamifant) is under development for the treatment of diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and adult onset Still’s disease (AOSD)), cytopenia and systemic lupus erythematosus (SLE), auto-immune and inflammatory diseases such as secondary hemophagocytic lymphohistiocytosis (HLH) and hyper-inflammatory syndrome, a complications associated with severe COVID-19 disease and It is administered as parenteral and intravenous route. The drug candidate acts by targeting interferon gamma. It was under development for the treatment of primary HLH. Emapalumab was under development for prevention of graft failure following hematopoietic stem cell transplantation and Graft failure.
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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