European Commission approval of Uplizna for the treatment of adults with neuromyelitis optica spectrum disorder.
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 on 11th November, 2021.
“NMOSD is a devastating disease with unpredictable attacks, cumulative and often irreversible damage and potential loss of vision and motor function, causing profound uncertainty for patients,” said Vikram Karnani, executive vice president and president, international, Horizon. “Today’s approval of Uplizna marks a significant milestone for patients in Europe and for Horizon, bringing a new, targeted treatment option to people living with NMOSD. As we continue our global expansion, we remain focused on bringing breakthrough medicines – and hope – to people living with challenging diseases. Across offices and manufacturing facilities on four continents, we deliver impact that goes beyond our medicines.”
In the N-MOmentum pivotal clinical trial (2014-000253-36), the largest NMOSD 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, 89% of patients in the AQP4-IgG+ group remained relapse-free during the six-month period post-treatment and more than 83% of patients on treatment remained attack free for at least four years.
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