The Food and Drug Administration (FDA) has approved UpliznaTM (inebilizumab-cdon; Viela Bio) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Inebilizumab, a humanized monoclonal antibody, is designed to bind with high affinity to CD19 resulting in the rapid depletion of B cells from the circulation, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells.

The approval was based on data from the pivotal N-MOmentum trial that evaluated the efficacy and safety of inebilizumab in 230 adult patients with NMOSD, including those with and without AQP4-IgG antibodies. Patients were randomized to receive 2 intravenous (IV) doses of inebilizumab monotherapy or placebo; patients were then placed into an open-label extension in which they all received inebilizumab for 6 months. The primary efficacy end point was time to onset of an adjudicated NMO/NMOSD attack. 

Results showed a 77% reduction in the risk of developing an NMOSD attack in AQP4-IgG positive patients treated with inebilizumab compared with placebo after 28 weeks (hazard ratio [HR]: 0.227 [95% CI, 0.121-0.423]; P <.0001). Moreover, patients treated with inebilizumab experienced a 73% reduction in the time to the first adjudicated relapse compared with placebo (HR: 0.272; P <.0001). Inebilizumab-treated patients also had reduced annualized rates of hospitalization compared with those who received placebo (0.11 vs 0.50, respectively). There was no evidence of a benefit in patients who were anti-AQP4 antibody negative. 

Regarding safety, the most common treatment-emergent adverse reactions were urinary tract infection and arthralgia. During the randomized clinical trial period, infusion reactions were observed with the first course of inebilizumab in 9.3% of NMOSD patients. Additionally, as has been seen with other B-cell-depleting therapies, treatment with inebilizumab may increase the risk of infections. Levels of quantitative serum immunoglobulins should be monitored during treatment, as progressive and prolonged hypogammaglobulinemia may occur. Inebilizumab can also cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to inebilizumab even after B-cell repletion.

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Uplizna is supplied as 100mg of inebilizumab in 10mL single-dose vials. The Company expects to launch the product in June 2020.

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