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AstraZeneca’ Soliris Receives the MHLW Approval for Paediatric Patients with Generalised Myasthenia Gravis

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AstraZeneca’ Soliris Receives the MHLW Approval for Paediatric Patients with Generalised Myasthenia Gravis

Shots:

  • 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

Related News:- AstraZeneca’ Soliris Receives EC’s Approval for Refractory Generalised Myasthenia Gravis in Children and Adolescents

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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