Inebilizumab-cdon (Uplizna®) received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), according to a press release from Horizon Therapeutics plc.
The decision is based on the results of a phase 2/3 clinical trial called N-MOmentum, which compared the efficacy of inebilizumab-cdon to placebo in reducing the risk of an NMOSD attack.
“In Europe, people living with NMOSD currently have very limited targeted treatment options and we look forward to advancing care for these patients who live daily with unpredictable attacks, pain and disability,” Tim Walbert, the chairman, president, and chief executive officer of Horizon said.
N-MOmentum was a multinational, multicenter, double-masked, randomized, placebo-controlled trial with an open-label extension period to evaluate the safety and efficacy of inebilizumab-cdon in patients with NMOSD, aged 18 years and older. The time of an NMOSD attack during the randomized controlled period was the primary outcome of the trial.
The results showed that the treatment reduced the risk of relapse by 77%, compared to placebo, in NMSOD patients who were anti-aquaporin-4 antibody positive (AQP4-IgG+).
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In NMOSD, the B-lymphocytes produce autoantibodies against the aquaporin-4 (AQP4) protein, which is predominantly found in the central nervous system, including the optic nerve, spinal cord, and brain stem. This causes blindness, muscle weakness, and paralysis.
Inebilizumab-cdon is a CD19 B-lymphocyte depleting antibody that reduces the risk of NMOSD attacks.
Inebilizumab-cdon is already approved in the US and Japan but not in the European Union, where there are an estimated 7300 patients with NMSOD, of whom 75% to 80% are AQP4-IgG+.
“Today’s positive CHMP opinion is a significant milestone in Horizon’s global growth and long-term commitment to address critical needs of those living with rare, autoimmune and severe inflammatory diseases,” Walbert said.
Horizon Therapeutics plc receives CHMP positive opinion for UPLIZNA® (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD). News release. Horizon; November 12, 2021.
N-MOmentum: a clinical research study of inebilizumab in neuromyelitis optica spectrum disorders. US National Library of Medicine. Last updated January 22, 2021. Accessed November 14, 2021.