Horizon Therapeutics plc receives CHMP positive opinion for Uplizna as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder.
Uplizna has been granted orphan designation by the European Commission (EC). That designation is subject to additional review by the Committee for Orphan Medicinal Products.
Based on the CHMP recommendation, a decision by the EC, if granted, would authorize marketing approval in the EU. This centralized marketing authorization would be valid in all EU Member States, as well as in Iceland, Liechtenstein and Norway.
Uplizna was approved by the FDA in June 2020 and by the Japanese Ministry of Health, Labour and Welfare in March 2021 as a targeted CD19 B-cell depleting antibody for adult patients with AQP4-IgG+ NMOSD, to reduce the risk of attacks. Uplizna is the only approved NMOSD therapy in the U.S. that has demonstrated a clinically relevant and durable effect on delaying worsening of disability, with a significant reduction in hospitalization.
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