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- The European Commission has approved Horizon Therapeutics plc's (NASDAQ: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.