Inebilizumab is under clinical development by Amgen and currently in Phase III for Immunoglobulin G4-Related Disease (IgG4-RD). According to GlobalData, Phase III drugs for Immunoglobulin G4-Related Disease (IgG4-RD) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Inebilizumab LoA Report. Buy the report here.
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.
Inebilizumab overview
Inebilizumab-cdon (Uplizna, Xinyue) is a CD19-directed glyco-engineered humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. It is formulated as solution for intravenous and intravenous drip route of administration. It is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Inebilizumab (MEDI-551) is under development for the treatment of systemic sclerosis, neuromyelitis optica spectrum disorder (NMOSD) in pediatrics, Myasthenia Gravis and IgG4-related disease. The drug candidate is administered through intravenous infusion and subcutaneous route. It is an immunoglobulin IgG1 kappa monoclonal antibody directed against the B-cell-specific membrane protein CD19.
It was also under development for the treatment of kidney transplant desensitization, relapsed and refractory chronic lymphocytic leukemia (CLL), relapsed or refractory diffuse large B-cell lymphoma, scleroderma, relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), progressive relapsing multiple sclerosis (PRMS), clinically isolated syndrome (CIS), multiple myeloma, follicular lymphoma, indolent lymphoma and mantle cell lymphoma.
Amgen overview
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.
For a complete picture of Inebilizumab’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.
