AstraZeneca’s potential medicine for neuromyelitis optica receives FDA Orphan Drug Designation

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9 March 2016

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody, MEDI-551, for the treatment of patients with neuromyelitis optica (NMO) as well as neuromyelitis optica spectrum disorders (NMOSD). Developed by MedImmune, MEDI-551 is currently in Phase IIb clinical development for NMO.

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