Inebilizumab is under clinical development by Horizon Therapeutics and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Inebilizumab’s likelihood of approval (LoA) and phase transition for Immunoglobulin G4-Related Disease (IgG4-RD) took place on 03 Aug 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 03 Aug 2021 decreased Inebilizumab’s LoA and PTSR for Myasthenia Gravis.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Inebilizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 adult patients with anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD), 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.

Horizon Therapeutics overview

Horizon Therapeutics formerly Horizon Pharma, is a pharmaceutical company, which develops and commercializes medical products for the treatment of rare, autoimmune, arthritis and severe inflammatory diseases. It markets medicines through its orphan, primary care and rheumatology business units. A few of the company’s marketed products include Actimmune, Buphenyl, Duexis, Krystexxa, Pennsaid, Procysbi, Quinsair, Ravicti, Rayos, Tepezza, Uplinza, and Vimovo. Horizon Therapeutics provides products and services to patients and healthcare professionals in the US. The company operates through offices in the US, Switzerland, Luxembourg, Bermuda, Germany, Canada, and Israel. Horizon Therapeutics is headquartered in Dublin, Ireland.

Quick View Inebilizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Inebilizumab
Administration Pathway
  • Intravenous
  • Intravenous Drip
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.