AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Soliris (eculizumab) to Treat Refractory Generalised Myasthenia Gravis
Shots:
- The EMA’s CHMP has recommended Soliris for marketing authorization in the EU to treat refractory gMG in children & adolescents aged 6-17yrs. who are AChR Ab+. The opinion was based on the P-III trial of Soliris in paediatric patients
- The results showed clinical benefit who previously failed immunosuppressive treatment & continued to experience unresolved disease symptoms, improvement in the 1EPs of change from baseline in QMG total score at 26wk. The efficacy & safety were consistent with the established profile of Soliris incl. adults with refractory gMG
- Soliris was approved in the EU for adults with gMG & also approved in the US, China & Japan while the regulatory submissions are ongoing or planned with multiple health authorities for paediatric patients
Ref: AstraZeneca | Image: AstraZeneca
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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.
