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

Author(s):

Faraat Ali*, Kamna Sharma, Varisha Anjum and Asad Ali   Pages 1 - 7 ( 7 )

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.

Affiliation:

Department of Inspection and Enforcement, Laboratory Services, Botswana Medicines Regulatory Authority, Plot 112, International Finance Park, Gaborone, Department of Pharmaceutical Analysis, Indo-Soviet Friendship College of Pharmacy, Moga, Punjab, Department of Pharmacognosy and Phytochemistry, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi - 110062, Department of Chemistry, School of Chemical and Life Sciences, Jamia Hamdard University, New Delhi



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