HZNP - Horizon's Uplizna gets approval in EU to treat nervous system disorder of eye spine
The European Commission (EC) approved Horizon Therapeutics' (NASDAQ:HZNP) Uplizna as a standalone therapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). Neuromyelitis optica is a central nervous system (CNS) disorder that occurs when the immune system reacts against its own cells in the CNS, mainly in the optic nerves and spinal cord (myelitis). NMOSD causes severe and recurrent CNS attacks which can lead to blindness and paralysis. The EC decision follows a recommendation of approval by the European Medicines Agency's Committee for Medicinal Products for Human Use in November 2021. The company said Uplizna (inebilizumab) is the EU's first and only targeted CD19+ B-cell-depleting monotherapy proven to reduce attacks in adult patients with AQP4-IgG+ NMOSD. Uplizna was approved in the U.S. in June 2020 and in Japan in March 2021.
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Horizon's Uplizna gets approval in EU to treat nervous system disorder of eye, spine