Likelihood of Approval and Phase Transition Success Rate Model – Obinutuzumab in Nephrotic Syndrome
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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.
Obinutuzumab in Nephrotic Syndrome Drug Details:
Obinutuzumab (Gazyva, Gazyvaro, Gaziva) is a glycoengineered, fully humanized IgG1 monoclonal antibody with anti-neoplastic activity. It is formulated as injectable concentrate solution for intravenous route of administration. Obinutuzumab is indicated for the treatment of chronic lymphocytic leukemia (CLL) and end-stage kidney disease (end-stage renal disease or ESRD), in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL), in combination with bendamustine followed by Gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen, and in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen.Obinutuzumab (a rituximab biobetter) is under development for the treatment of systemic lupus erythematosus, hairy cell leukemia, lupus nephritis, graft versus host disease (GVHD), Waldenstrom macroglobulinemia, membranous nephropathy, non-Hodgkin lymphoma, diffuse large B-cell lymphoma, nodal, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, metastatic melanoma and idiopathic nephrotic syndrome. It is also under development for follicular lymphoma in Japan. It is administered through intralesional and intravenous route. It is a new molecular entity (NME).It was also under development for the treatment of end stage kidney disease, non-Hodgkin lymphoma, cutaneous t-cell lymphoma, relapsed and refractory chronic lymphocytic leukemia marginal zone lymphoma (MZL), follicular lymphoma (FL), extranodal and splenic marginal zone lymphoma and mantle cell lymphoma.
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
- 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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