Soliris recommended for approval in the EU by CHMP for children and adolescents with refractory generalised myasthenia gravis (gMG)
Potential approval for Soliris would mark first and only targeted treatment for this patient population in the European Union.The first-in-class C5 inhibitor reduced disease severity and symptoms with sustained improvements over 26 weeks in Phase III clinical trial.Soliris (eculizumab) has been recommended for marketing authorisation in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). If authorised, Soliris