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Alexion : Japan Okays Soliris For Prevention Of Relapse In Patients With NMOSD

Alexion Pharmaceuticals Inc. (ALXN) said that Japan's Ministry of Health, Labour and Welfare has approved the extension of the current marketing authorization of SOLIRIS (eculizumab) to include the prevention of relapse in patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder or NMOSD, including neuromyelitis optica.

NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses, also referred to as attacks. Each attack can result in stepwise accumulation of disability, including blindness and paralysis and sometimes premature death.

SOLIRIS was approved for the treatment of NMOSD in adult patients who are anti-AQP4 antibody-positive by the U.S. Food and Drug Administration (FDA) in June 2019 and by the European Commission in August 2019.

SOLIRIS received Orphan Drug Designation for the treatment of NMOSD in the U.S., EU and Japan.

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