AstraZeneca gains approvals in Japan for Soliris and Lynparza
UK pharma major AstraZeneca (LSE: AZN) today announced extended indication approvals of two major products in Japan.
First, the company’s Soliris (eculizumab) has been approved in Japan for expanded use to include the treatment of generalized myasthenia gravis (gMG) in pediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris is the first and only targeted therapy approved for the treatment of children and adolescents with gMG in Japan, according to AstraZeneca.
The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on results from the Phase III trial of Soliris in pediatric patients with refractory gMG. 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 USA, China and the European Union (EU).
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