AstraZeneca’ Soliris Receives the MHLW Approval for Paediatric Patients with Generalised Myasthenia Gravis
- The MHLW approved Soliris for expanded use to include the treatment of gMG in pediatric patients who are AChR Ab+ & whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmapheresis
- The approval was based on the P-III trial evaluating Soliris in 11 patients aged 12-17yrs. which showed a clinical benefit who previously failed immunosuppressive treatment & continued to experience unresolved disease symptoms
- Improvement in 1EPs of change from baseline in QMG total score at 26wk., efficacy & safety were consistent with the established profile of Soliris. Soliris was approved in Japan for adults with gMG, and was also approved in the US, China & the EU while regulatory submissions are ongoing or planned with multiple health authorities
Ref: AstraZeneca | Image: AstraZeneca
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