The European Commission (EC) has granted approval for Horizon Therapeutics’ Uplizna (inebilizumab) as monotherapy to treat neuromyelitis optica spectrum disorder (NMOSD) in adults.
The treatment is intended for NMOSD patients who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).
In November last year, the Committee for Medicinal Products for Human Use of the European Medicines Agency provided a positive opinion for Uplizna to treat NMOSD.
The latest approval is based on findings from the double-blind, multicentre, randomised, placebo-controlled Phase II/III N-MOmemtum clinical trial carried out in 25 countries.
Results showed that Uplizna demonstrated a substantial decline in the risk of an NMOSD attack with two infusions a year, following the preliminary loading doses.
Nearly 87.6% of trial subjects who received Uplizna were attack free for 28 weeks.
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Furthermore, 89% of subjects in the AQP4-IgG+ group were relapse-free during six months following treatment while over 83% of those on treatment remained attack free for a minimum of four years.
With the approval, Uplizna is valid for usage in all EU countries and Iceland, Liechtenstein and Norway.
Uplizna received approval from the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare as a targeted CD19 B-cell depleting antibody to treat AQP4-IgG+ NMOSD in adults, to lower the attack risk.
Horizon Therapeutics international executive vice-president and president Vikram Karnani said: “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.
“The 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.”
A rare neuroinflammatory autoimmune ailment, NMOSD attacks the optic nerve, spinal cord, brain and brain stem.
In June last year, Horizon and Arrowhead Pharmaceuticals signed a global collaboration and licence agreement for developing the latter’s ribonucleic acid interference therapeutic, ARO-XDH.