Soliris now approved in EU for children with refractory gMG

27 July 2023

UK pharma major AstraZeneca (LSE: AZN) this morning revealed that Soliris (eculizumab) has been approved in the European Union (EU) for expanded use.

This will include the treatment of refractory generalized myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). This is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the Phase III trial of Soliris in pediatric patients with refractory gMG.

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