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Current Drug Discovery Technologies

Author(s): Faraat Ali*, Kamna Sharma, Varisha Anjum and Asad Ali

DOI: 10.2174/1570163818666210519103001

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Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder)

Article ID: e140122193419 Pages: 7

  • * (Excluding Mailing and Handling)

Abstract

Inebilizumab-cdon (Uplizna™) was currently approved by the United States Food and Drug Administration (USFDA) for the treatment of NMOSD (neuromyelitis optica spectrum disorder). It was developed by Viela Bio (Nasdaq: VIE) USA. Inebilizumab-cdon (formerly MEDI-551) is a humanized antibody, which induces CD19 + B cell depletion by increasing antibody-dependent cell cytotoxicity (ADCC) and cell phagocytosis (ADCP) of effector cells. Various clinical trials exhibit its safe and effective pharmacokinetic and pharmacodynamic profile. In June 2019, Viela Bio submitted Biologics License Application (BLA) to the FDA based on the findings obtained from the N-Momentum trial. This article summarizes the milestones in the development of Inebilizumab-cdon leading to this approval for the treatment of advanced NMOSD.

Keywords: Inebilizumab-cdon (Uplizna™), NMOSD, viela bio, neuroinflammatory autoimmune disease, neuromyelitis optica spectrum disorder, CD19-directed monoclonal antibody.

[1]
FDA Approves Uplizna (Inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD). 2020. Available at: https://www.drugs.com
[2]
Cree BA. Placebo controlled trials in neuromyelitis optica are needed and ethical. Mult Scler Relat Disord 2015; 4(6): 536-45.
[http://dx.doi.org/10.1016/j.msard.2015.07.017] [PMID: 26590660]
[3]
Beh C S, Frohman T C, Frohman E M. Neuromyelitis Optica: Immunopathogenesis, Clinical Manifestations, and Treatments. Curr Clin Neurol
[4]
Ohmachi K, Ogura M, Suehiro Y, et al. A multicenter phase I study of inebilizumab, a humanized anti-CD19 monoclonal antibody, in Japanese patients with relapsed or refractory B-cell lymphoma and multiple myeloma. Int J Hematol 2019; 109(6): 657-64.
[http://dx.doi.org/10.1007/s12185-019-02635-9] [PMID: 30915717]
[5]
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve Spinal Cord 2020; 15.
[6]
Fujihara K, et al. Neuromyelitis optica should be classified as an astrocytopathic disease rather than a demyelinating disease. Clin Exp Neuroimmunol 2012; 58-73.
[http://dx.doi.org/10.1111/j.1759-1961.2012.00030.x]
[7]
Matlawska-Wasowska K, Ward E, Stevens S, et al. Macrophage and NK-mediated killing of precursor-B acute lymphoblastic leukemia cells targeted with a-fucosylated anti-CD19 humanized antibodies. Leukemia 2013; 27(6): 1263-74.
[http://dx.doi.org/10.1038/leu.2013.5] [PMID: 23307031]
[8]
Wingerchuk D, Marignier R, Bennett JL, et al. (DXT15) Inebilizumab Reduces Neuromyelitis Optica Spectrum Disorder Disability Worsening: Outcomes and Long-Term Follow-up Data from the N-MOmentum Trial. Int J MS Care 2020; 22: 21-2.
[9]
Inebilizumab, Statement on a nonproprietary name adopted by the USAN council. 2014.
[10]
Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (Inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).2020. Available at: www.vielabio.com
[11]
Form S-1 Viela Bio, Inc. 2020.
[12]
Gallagher S, Turman S, Yusuf I, et al. Pharmacological profile of MEDI-551, a novel anti-CD19 antibody, in human CD19 transgenic mice. Int Immunopharmacol 2016; 36: 205-12.
[http://dx.doi.org/10.1016/j.intimp.2016.04.035] [PMID: 27163209]
[13]
UPLIZNA- Inebilizumab injection Viela Bio, Inc. 2020.
[14]
Agius MA. Safety and tolerability of Inebilizumab (MEDI551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study. Mult Scler 1-11.
[15]
Traub J, Husseini L, Weber MS. B Cells and Antibodies as Targets of Therapeutic Intervention in Neuromyelitis Optica Spectrum Disorders. Pharmaceuticals (Basel) 2021; 14(1): 37.
[http://dx.doi.org/10.3390/ph14010037] [PMID: 33419217]
[16]
Wingerchuk DM, Lennon VA, Pittock SJ, Lucchinetti CF, Weinshenker BG. Revised diagnostic criteria for neuromyelitis optica. Neurology 2006; 66(10): 1485-9.
[http://dx.doi.org/10.1212/01.wnl.0000216139.44259.74] [PMID: 16717206]
[17]
Wingerchuk DM, Lennon VA, Lucchinetti CF, Pittock SJ, Weinshenker BG. The spectrum of neuromyelitis optica. Lancet Neurol 2007; 6(9): 805-15.
[http://dx.doi.org/10.1016/S1474-4422(07)70216-8] [PMID: 17706564]
[18]
Chojdak-Łukasiewicz J. Neuromyelitis optica (NMO) – a challenging demyelinative disorder. Advances in Biomedical Research – from COVID to Medical Humanities
[19]
Mokaberi P, Babayan-Mashhadi F, Amiri Tehrani Zadeh Z, Saberi MR, Chamani J. Analysis of the interaction behavior between Nano-Curcumin and two human serum proteins: combining spectroscopy and molecular stimulation to understand protein-protein interaction. J Biomol Struct Dyn 2020; 1-20.
[http://dx.doi.org/10.1080/07391102.2020.1766570] [PMID: 32397834]
[20]
Saadoun S, Waters P, Bell BA, Vincent A, Verkman AS, Papadopoulos MC. Intra-cerebral injection of neuromyelitis optica immunoglobulin G and human complement produces neuromyelitis optica lesions in mice. Brain 2010; 133(Pt 2): 349-61.
[http://dx.doi.org/10.1093/brain/awp309] [PMID: 20047900]
[21]
Jarius S, Frederikson J, Waters P, et al. Frequency and prognostic impact of antibodies to aquaporin-4 in patients with optic neuritis. J Neurol Sci 2010; 298(1-2): 158-62.
[http://dx.doi.org/10.1016/j.jns.2010.07.011] [PMID: 20850793]
[22]
Mokaberi P, Reyhani V, Amiri-Tehranizadeh Z, et al. New insights into the binding behavior of lomefloxacin and human hemoglobin using biophysical techniques: binary and ternary approaches. New J Chem 2019; 43: 8132-45.
[http://dx.doi.org/10.1039/C9NJ01048C]
[23]
Chamani J. Multi-spectroscopic and molecular modeling studies to reveal the interaction between propyl acridone and calf thymus DNA in the presence of histone H1: Binary and ternary approaches. J Biomol Struct Dyn 2018.
[PMID: 29338579]
[24]
Verkman A S, Ratelade J. Neuromyelitis optica: Aquaporin-4 based pathogenesis mechanisms and new therapies. Int j biochem cell B 2012; 44: 1519-30.
[25]
Duchow A, Paul F, Strobl Bellmann. Current and Emerging Biologics for the Treatment of Neuromyelitis Optica Spectrum Disorders. Expert opin biol th 2020.
[26]
Cree BA, Bennett JL, Sheehan M, et al. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler 2016; 22(7): 862-72.
[http://dx.doi.org/10.1177/1352458515620934] [PMID: 26666258]
[27]
Inebilizumab in Follow-On Indications - Viela Bio. 2020.
[28]
Uplizna (Inebilizumab-cdon injection). 2020. Available at: https://www.rxlist.com/uplinza-drug.htm#description
[29]
Sohrabi T, Hosseinzadeh M, Beigoli S, et al. Probing the binding of lomefloxacin to a calf thymus DNA-histone H1 complex by multi-spectroscopic and molecular modeling techniques. J Mol Liq 2018; 256: 127-38.
[http://dx.doi.org/10.1016/j.molliq.2018.02.031]
[30]
Chen D, Gallagher S, Monson NL, Herbst R, Wang Y. Inebilizumab, a B Cell-Depleting Anti-CD19 Antibody for the Treatment of Autoimmune Neurological Diseases: Insights from Preclinical Studies. J Clin Med 2016; 5(12): 107.
[http://dx.doi.org/10.3390/jcm5120107] [PMID: 27886126]
[31]
Kamshad M, Talab MJ, Beigoli S, et al. Use of spectroscopic and zeta potential techniques to study the interaction between lysozyme and curcumin in the presence of silver nanoparticles at different sizes. J Biomol Struct Dyn 2018.
[PMID: 29757090]
[32]
Schiopu E, Chatterjee S, Hsu V, et al. Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. Arthritis Res Ther 2016; 18(1): 131.
[http://dx.doi.org/10.1186/s13075-016-1021-2] [PMID: 27267753]
[33]
Cree B, Bennett J, Kim HJ, et al. A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adult Subjects with Neuromyelitis Optica Spectrum Disorders-Top line efficacy and safety results. Neurology 2019; 92.
[34]
Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial Available at: www.thelancet.com
[35]
Xie Q, Sun M, Sun J, Zheng T, Wang M. New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review). Exp Ther Med 2021; 21: 2-148.
[http://dx.doi.org/10.3892/etm.2020.9579]
[36]
Chen D, Ireland SJ, Davis LS, et al. Autoreactive CD19+CD202 Plasma Cells Contribute to Disease Severity of Experimental Autoimmune Encephalomyelitis. J Immunol 2016; 196.