AstraZeneca Announces Approval Of Soliris In Japan For Expanded Use

(RTTNews) - AstraZeneca reported that Soliris has been approved in Japan for expanded use to include the treatment of generalised myasthenia gravis in paediatric patients who are anti-acetylcholine receptor antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmapheresis. The approval by the Japanese Ministry of Health, Labour and Welfare was based on results from the Phase III trial of Soliris.

Soliris was first approved in Japan in 2017 for the treatment of certain adults with gMG and is also approved for certain adults with gMG in the US, China and the European Union.

Marc Dunoyer, CEO, Alexion, said: "Our first-in-class C5 inhibitor Soliris has the potential to improve outcomes and quality of life for paediatric patients and their families, and we take pride in delivering this first and only targeted therapy to the paediatric gMG community in Japan."

Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the acquisition of Alexion Pharmaceuticals, Inc.

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