AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris® is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU. The company also confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are currently ongoing or planned with various health authorities.
The approval follows the CHMP recommendation for approval of the new indication on 26 June 2023.