Hor Horizon Therapeutics plc announced that on December 15, 2023, Health Canada approved UPLIZNA®? (inebilizumab for injection) as a monotherapy for the treatment of adult patients with NMOSD who are AQP4-IgG+. This rare autoimmune disease is caused by inflammation in the central nervous system, resulting in severe and recurrent attacks that can lead to permanent disability, such as vision loss and paralysis.1 An estimated 1,000 people in Canada live with the disease.

Health Canada based its approval of UPLIZNA on results from the N-MOmentum pivotal trial (2014-000253-36), the NMOSD clinical trial to date. UPLIZNA demonstrated a significant reduction in the risk of an NMOSD attack with only two infusions per year, following the initial loading doses. Additionally, 87.6% of patients in the AQP4-IG+ group remained relapse-free during the six-month period post-treatment.5 UPLIZNA also demonstrated an acceptable safety profile.

People impacted by NMOSD live with unpredictable attacks; 90% will experience repeat attacks within five years of an initial attack.7 Damage is caused when CD19+-expressing B-cell lymphocytes (plasmablasts and some plasma cells) secrete AQP4-Ig G, triggering an escalating autoimmune reaction. Depletion of CD19+ B-cells has proven effective at halting inflammation, lesion formation and astrocyte loss. UPLIZNA offers a unique mode of action developed specifically to deplete CD19+ B-cells and prevent attacks.

UPLIZNA was approved by the U.S. Food and Drug Administration (FDA) in June 2020, by the Japanese Ministry of Health, Labor and Welfare in March 2021, by the European Commission (EC) in April 2022 and by the Brazilian Health Regulatory Agency (ANVISA) in December 2022.