Horizon Therapeutics plc announced the European Commission (EC) approval of UPLIZNA® (inebilizumab) as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+), following the positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
People impacted by NMOSD live with unpredictable attacks; 90% will experience repeat attacks within five years of an initial attack. Even a single NMOSD attack can result in significant, irreversible damage, with each subsequent attack building upon the damage caused by the previous. This damage is caused when CD19+-expressing B-cell lymphocytes (plasmablasts and some plasma cells) secrete AQP4-IgG, triggering an escalating autoimmune reaction. Depletion of CD19+ B-cells has proven effective at halting inflammation, lesion formation and astrocyte loss. As a targeted CD19 B-cell depleter, UPLIZNA offers a unique mode of action developed specifically to induce broad, deep and durable B-cell depletion and prevent attacks. Maintaining B-cell depletion and preventing attacks are key to limiting cumulative disability within NMOSD. Read more here.