AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the MA for Astra Zeneca’s Soliris® (eculizumab) be expanded to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor antibody-positive. AZ confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are pending or planned with multiple health authorities.
On 13 June 2023 the Chinese NMPA approved Soliris® for treatment of gMG in adults who are anti-acetylcholine receptor antibody-positive.