AstraZeneca’ Soliris Receives EC’s Approval for Refractory Generalised Myasthenia Gravis in Children and Adolescents
- The EC has approved Soliris (C5 complement inhibitor) for expanded use to include the treatment of refractory gMG in children & adolescents aged 6-17yrs. who are AChR Ab+. The approval was based on the P-III trial of Soliris in 11 patients aged 12-17yrs. with refractory gMG
- The results showed a clinical benefit in paediatric patients who previously failed immunosuppressive treatment & experienced significant unresolved disease symptoms, improvement in 1EPs of change from baseline in QMG total score were seen at 26wk.
- The efficacy & safety of Soliris was consistent with the established profile of Soliris in clinical trials incl. adults with refractory gMG. Soliris was approved in the US, EU & Japan for adults with NMOSD
Ref: AstraZeneca | Image: AstraZeneca
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