The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the immunosuppressant inebilizumab (Uplizna, Horizon Therapeutics) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive.
NMOSD is a rare, severely disabling, complement-mediated autoimmune neuroinflammatory disease of the central nervous system, characterized by devastating and unpredictable relapses that can cause immediate and irreversible damage.
Inebilizumab, which had orphan drug designation, binds to the B cell-specific surface antigen CD19, leading to a profound depletion of B cells, which are believed to play a central role in the pathogenesis of NMOSD.
The drug can help reduce the risk of attacks in AQP4-IgG seropositive NMOSD. The most common side effects are urinary tract infections, joint pain, and reduction of immunoglobulins levels.
Once approved in Europe, inebilizumab will be available as a 100-mg concentrate for solution for infusion.
Inebilizumab should be prescribed by physicians experienced in the treatment of NMOSD and with access to appropriate medical support to manage potential severe reactions such as serious infusion-related reactions, the EMA said.
Detailed recommendations for the use of inebilizumab will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after marketing authorization has been granted by the European Commission.
Lead Image: Horizon Therapeutics
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Cite this: EMA Panel Backs Uplizna for Neuromyelitis Optica - Medscape - Nov 15, 2021.