Horizon Says UPLIZNA Approved By Brazilian Health Regulatory Agency As Monotherapy For NMOSD
(RTTNews) - Biotechnology company Horizon Therapeutics plc (HZNP) announced Tuesday that the Brazilian Health Regulatory Agency (ANVISA) has approved UPLIZNA as a monotherapy for the treatment of adult patients with NMOSD who are AQP4-IgG+.
This rare autoimmune disease is caused by inflammation in the central nervous system, resulting in severe and recurrent attacks that can lead to permanent disability, such as paralysis and vision loss. An estimated 10,000 people in Brazil live with the disease.
A primary goal of treatment is to help prevent cumulative damage and permanent disability that can be caused by subsequent attacks.
In the N-MOmentum pivotal clinical trial, UPLIZNA demonstrated a significant reduction in the risk of an NMOSD attack with only two infusions per year, following the initial loading doses.
UPLIZNA was approved by the U.S. Food and Drug Administration (FDA) in June 2020, by the Japanese Ministry of Health, Labor and Welfare in March 2021 and by the European Commission (EC) in April 2022.
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