Likelihood of Approval and Phase Transition Success Rate Model – Immune Globulin (Human) in Immune Mediated Necrotizing Myopathy (IMNM)
Powered by
Unlock hidden opportunities in the LoA industry
Empower your strategies with our Likelihood of Approval and Phase Transition Success Rate Model – Immune Globulin (Human) in Immune Mediated Necrotizing Myopathy (IMNM) report and make more profitable business decisions.
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 Immune Mediated Necrotizing Myopathy (IMNM)Drug Details:
Human immunoglobulin (Privigen / Hizentra / Beriglobin / Beriglobina P / Beriglobin P / Sandoglobuline / Vivaglobin / Intragam / Privigen AU / Hizentra AU / Evogam / Carimune NF / Sandoglobulin / Behrigamma / Sandoglobulin NF / Armoglobulina P / Gama Venina / Venimmuna N ) is a liquid formulation of human immunoglobulin (Ig). It is formulated as Privigen injectable solution for intravenous administration, Carimune NF lyophilized powder for solution for intravenous administration and as Hizentra injectable solution for subcutaneous administration. Hizentra is indicated for the treatment of primary immunodeficiency (PI). Privigen is used for treatment of primary humoral immunodeficiency and chronic immune thrombocytopenic purpura Privigen is purified from the pooled plasma of thousands of healthy donors, so it contains a wide variety of the antibody specificities and idiotypes available in the general human population. It is also indicated for the treatment of Hypogammaglobulinaemia. This allows Privigen to be used for the treatment of immune disorders requiring immunoglobulin replacement. It acts by suppling opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic and mycoplasma agents and their toxins. Privigen is also indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability, and for the treatment of hypogammaglobulinemia and agammaglobulinemia.The drug candidate is under development for the treatment of primary immune deficiency, autoimmune epilepsy, dermatomyositis, acute traumatic spinal cord injury, diffuse cutaneous systemic sclerosis (subcutaneous formulation), immune-mediated necrotizing myopathy, idiopathic inflammatory myopathies and primary immunodeficiency syndromes with impaired antibody production and secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of less than 4 g/l. It was also under development for the treatment of Guillain-Barre syndrome and diffuse cutaneous systemic sclerosis (intravenous formulation).
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.
Quick View – Immune Globulin (Human) LOA Data | |||||
Report Segments |
|
||||
Drug Name |
|
||||
Administration Pathway |
|
||||
Therapeutic Areas |
|
||||
Key Manufacturers |
|
||||
Drug Development Status |
|
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
Get in touch to find out about multi-purchase discounts
reportstore@globaldata.com
Tel +44 20 7947 2745