Ianalumab is under clinical development by Novartis and currently in Phase III for Acquired (Autoimmune) Hemolytic Anemia. According to GlobalData, Phase III drugs for Acquired (Autoimmune) Hemolytic Anemia have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ianalumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Ianalumab overview
Ianalumab is under development for the treatment of autoimmune hepatitis, primary Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, B-Cell Non-Hodgkin Lymphomas including diffuse large B-cell lymphoma, follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), autoimmune hemolytic anemia, primary immune thrombocytopenia and lupus nephritis. The therapeutic candidate is administered through subcutaneous and intravenous routes. It is a fully human IgG1/k mAb with a dual mode of action targeting B-cell lysis and by targeting BAFF receptor (BAFF-R). The therapeutic candidate is based on HuCAL (human combinatorial antibody library) technology. It is a new molecular entity (NME).
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The drug candidate was also under development for the treatment of relapsed or refractory chronic lymphocytic leukemia, chronic lymphocytic leukemia, pemphigus vulgaris, idiopathic pulmonary fibrosis and relapsing-remitting multiple sclerosis (RRMS).
Novartis overview
Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.
For a complete picture of Ianalumab’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
