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Japan approves Alexion's Soliris for neuromuscular disorder

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Japan approves Alexion's Soliris for neuromuscular disorder

Japan's Ministry of Health, Labour and Welfare approved Alexion Pharmaceuticals Inc.'s Soliris for the treatment of patients with a neuromuscular disorder known as generalized myasthenia gravis, or gMG.

The approval is based on the positive outcome of the phase 3 Regain study which evaluated the drug's safety and efficacy in treating the chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles.

Soliris, also known as eculizumab, is the first and only complement inhibitor approved in Japan as a treatment for gMG patients who are anti-acetylcholine receptor antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmapheresis.

The drug is already approved for the same indication in the EU and the U.S.