Likelihood of Approval and Phase Transition Success Rate Model – Ustekinumab in Type 1 Diabetes (Juvenile Diabetes)
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Overview
How likely is it that a drug will get approved? Will the drug transition to the next phase of its clinical pathway? 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 GlobalDatas proprietary machine learning algorithms developed using over 10 years of historical data.
Ustekinumab in Type 1 Diabetes (Juvenile Diabetes) Drug Details:
Ustekinumab (Stelara, Finlius) is a human monoclonal antibody used as immunosuppressant. It is produced by a recombinant DNA technology. It is formulated as a injectable solution for injection, powder for solution and solution for injection in pre-filled syringe for subcutaneous and intravenous route and injectable concentrate solution for subcutaneous route of administration. It is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, for the treatment of adult patients (18 years or older) with active psoriatic arthritis (PsA), alone or in combination with methotrexate. Stelara is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies, for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers, and for the treatment of adult patients with moderately to severely active ulcerative colitis. Stelara is also indicated for the treatment of pediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis. Stelara is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Ustekinumab is under development for the treatment of active juvenile psoriatic arthritis, ichthyosis, pouchitis and Crohn’s disease in pediatrics, ulcerative colitis in pediatrics, Takayasu Arteritis and type 1 diabetes mellitus. It is based on UltiMAb technology. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. It was also under development for the treatment of sarcoidosis, active radiographic or non-radiographic axial spondyloarthritis, primary biliary cirrhosis (PBC), rheumatoid arthritis, hidradenitis suppurativa, severe atopic dermatitis, and relapsing-remitting multiple sclerosis. It was under development for systemic lupus erythematosus, active polymyositis and dermatomyositis.
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. GlobalDatas 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
– Predict the specific likelihood of approval and phase transition success rates of a drug using a combination of machine learning and proprietary models
– Get information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies
– Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR
– Use PTSR and LOA information and event-driven changes for your investment decisions.
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
- Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
- 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.
- Generic drugs
- 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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