Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 110 |
| INN | Inebilizumab |
| Status | Approved |
| Drug code(s) | MT-0551, MEDI-551 |
| Brand name | Uplizna |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display for affinity maturation |
| Target(s) | CD19 |
| Indications of clinical studies | IgG4 Related Disease, Myasthenia Gravis, Neuromyelitis Optica, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Scleroderma, Multiple Sclerosis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Canada, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2009 |
| Start of Phase 2 | February 15, 2012 |
| Start of Phase 3 | January 15, 2015 |
| Date BLA/NDA submitted to FDA | June 11, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | June 11, 2020 |
| INN, US product name | Inebilizumab, inebilizumab-cdon |
| US or EU approved indications | Treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 or AQP4 antibody positive |
| Company | AstraZeneca |
| Licensee/Partner | Viela Bio, Mitsubishi Tanabe, Hansoh Pharmaceutical |
| Comments about company or candidate | May 02, 2022 I Horizon Therapeutics plc announced the European Commission (EC) approval of UPLIZNA® (inebilizumab) as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+), following the positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency on 11th November, 2021. Oct 2019: Viela Bio and Mitsubishi Tanabe Pharma (MTPC) announced a collaboration focused on the development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in nine Asia regions for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.August 27, 2019 –Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for inebilizumab, an investigational anti-CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. In May 2019, Viela Bio and Hansoh Pharmaceutical announced a collaboration focused on development and commercialization of inebilizumab in China for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential inflammation/autoimmune and hematologic malignancy indications.Under terms of the collaboration, Viela will receive an up-front collaboration fee and additional payments contingent on certain development, regulatory, and commercial milestones, totaling potentially more than $220 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China. April 18, 2019 – Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder. January 3, 2019: Viela Bio today announced that N-MOmentum, a pivotal trial of inebilizumab, met its primary and key secondary endpoints in patients with neuromyelitis optica spectrum disorder (NMOSD). Feb 2018: MedImmune is spinning out this asset from its early-stage inflammation and autoimmunity programmes into an independent biotech company, Viela Bio. The new company will focus on developing medicines for severe autoimmune diseases by targeting the underlying causes of each disease. March 2017: EU orphan for the treatment of neuromyelitis optica spectrum disorder. March 2016: MEDI-551 granted US orphan-drug status as a treatment for neuromyelitis optica. NCT02200770 Phase 2/3 study in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders recruiting as of April 2015 NCT00946699 started in March 2010. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Made in fucosyltransferase-deficient CHO (Chinese Hamster Ovary) cells (POTELLIGENT technology)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |