Likelihood of Approval and Phase Transition Success Rate Model – Anakinra in Cytokine Release Syndrome (Cytokine Storm)
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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.
Anakinra in Cytokine Release Syndrome (Cytokine Storm) Drug Details:
Anakinra (Kineret) is an immunosuppressant produced in Escherichia coli cells by recombinant DNA technology. It is formulated as a solution for subcutaneous route of administration. Kineret is indicated in adults for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, with an inadequate response to methotrexate alone, in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS).Kineret is indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). Kineret is indicated for the treatment of coronavirus disease (COVID-19) in adult patients with pneumonia requiring supplemental oxygen. Anakinra is under development for the treatment of sepsis, pancreatic ductal adenocarcinoma (PDAC), chronic lymphocytic leukemia (CLL), cryopyrin-Associated Periodic syndromes, mucopolysaccharidosis III, bladder pain syndrome, autoimmune inner ear disease, acute myocarditis, intracerebral hemorrhage, familial mediterranean fever, cystitis and COVID-19 pneumonia. It is also under development for treatment of hyper-inflammatory syndrome, complications associated with COVID-19 disease and cytokine release syndrome (CRS). It is administered through subcutaneous, intravenous and periarticular routes. It was under development for metastatic adenocarcinoma of the pancreas, mucocutaneous lymph node syndrome (Kawasaki Disease), hidradenitis suppurativa, systemic-onset juvenile idiopathic arthritis (Still Disease) and adult onset Still disease (AOSD), acute gout, hospital acquired pneumonia, community acquired pneumonia and metastatic breast cancer. It is administered through intravenous drip and intravenous bolus route.It was under development for the treatment of traumatic brain injury and ulcerative colitis.
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
This is an on-demand report that will be delivered upon request. The report will be delivered within 2 business days of the purchase, excluding weekends and holidays. Certain sections of the report may be removed or altered based on data availability and relevance.
Frequently asked questions
- Drugs which have been approved in the past 10 years
- Drugs which have failed during clinical development in the past 18 years
- Drugs which are currently in development
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- Drugs must meet one of the following criteria to be included in the model:
- The developer has specified the US as an intended market for approval.
- The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”
- Innovator drugs and biosimilars
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- Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
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- Innovative drugs in Preclinical or Discovery Stage.
- Pipeline drugs sponsored by a Government or Institution.
- Drugs with a specific Drug Geography not the United States.
The probability of a drug ultimately receiving market authorization
The probability of a drug’s advancement to the next stage of clinical development
GlobalData’s Drug-Specific Likelihood of Approval (LoA) calculates the Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases.
Inclusion
Data Scope:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
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