Expansion of indications for AZ’s Soliris® (eculizumab)

Jun 26, 2023

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.

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