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Viela Bio's Uplizna (inebilizumab-cdon) Receives the US FDA's Approval to Treat Neuromyelitis Optica Spectrum Disorder (NMOSD)

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Viela Bio's Uplizna (inebilizumab-cdon) Receives the US FDA's Approval to Treat Neuromyelitis Optica Spectrum Disorder (NMOSD)

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  • The approval is based on N-MOmentum trial which involves assessing of Uplizna (300mg) vs placebo in 213 patients in the ratio (3:1) at day 1 to day 15 who are anti-AQP4 antibody-positive/negative   
  • The study resulted in anti-AQP4 antibody-positive group remained relapse-free (89% vs 58%) including reductions in NMOSD-related hospitalizations with safety and tolerability profile
  • Uplizna (inebilizumab-cdon) is a humanized CD19-directed mAb and is a novel B cell depleter approved for the treatment of NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive

Ref: Viela | Image: Signbox

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