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AstraZeneca’s Soliris approved in Japan for paediatric gMG patients

The drug is the first to be approved in Japan to treat children and adolescents with generalised myasthenia gravis.

AstraZeneca has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Soliris (eculizumab) for the extended use of treating generalised myasthenia gravis (gMG) in paediatric patients who are anti-acetylocholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with other treatments.

This drug is the first to be approved in Japan for the treatment of children and adolescents with gMG, with approval following results from a phase 3 trial of Soliris. This trial demonstrated clinical benefit in indicating this in patients who previously failed immunosuppressive treatment.

Keiko Ishigaki, Department of Pediatrics at Tokyo Women’s Medical University, School of Medicine, Japan, commented: “gMG is challenging to manage in paediatric patients, as current therapies available to this population, such as immunosuppressants, may not offer adequate control as the disease progresses.

“[The] expanded approval of Soliris in Japan demonstrates the impact of C5 complement inhibition in treating gMG, offering paediatric patients a targeted option with the potential to preserve muscle function and reduce disease severity.”

Marc Dunoyer, chief executive officer of Alexion, a subsidiary of AstraZeneca, added: “Paediatric patients living with gMG can become nonresponsive to standard treatments and continue to experience symptoms that impact their mobility, speech and breathing.

“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.”