Horizon Therapeutics' Inebilizumab Scores European Approval For Spinal Cord Inflammation

  • The European Commission has approved Horizon Therapeutics plc's HZNP Uplizna (inebilizumab) as monotherapy for neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).
  • NMOSD is an autoimmune disease that attacks the optic nerve, spinal cord, brain, and brain stem.
  • In the N-MOmentum pivotal clinical trial, Uplizna demonstrated a significant reduction in the risk of an NMOSD attack with only two infusions per year following the initial loading doses. 
  • Related: Horizon Therapeutics' Uplinza Reduces Severity of Attacks Associated Spinal Cord Inflammation.
  • Additionally, 89% of patients in the AQP4-IgG+ group remained relapse-free during the six months post-treatment, and more than 83% of patients on treatment remained attack free for at least four years.
  • The FDA approved Uplizna in June 2020.
  • Price Action: HZNP shares are down 3.31% at $95.30 during the market session on the last check Monday.
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