Horizon gains reimbursement of inebilizumab for NMOSD in Italy

30 March 2023

Ireland-headquartered biotech Horizon Therapeutics (Nasdaq: HZNP) today announced that the Italian medicines regulator, the AIFA, has approved the reimbursement of inebilizumab for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD).

Approved and marketed in several geographies included the USA and European Union under the trade name Uplinza, inebilizumab is the newest medicine approved at the European level for the treatment of NMOSD. With a new and unique mechanism of action, inebilizumab is a humanized afucosylated monoclonal antibody able to deplete B cells by binding to the specific surface antigen CD19, reaching and causing the specific depletion of the cells primarily involved in the pathogenic process.

Inebilizumab is authorized by the European Commission as monotherapy for the treatment of adult patients with NMOSD who are seropositive for anti acuaporin-4 immunoglobulin G (AQP4-IgG) antibodies, which accounts for 60-75% of patients with this disease.

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