On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of age or older with generalised myasthenia gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.
This approval means Soliris® (eculizumab) is the first and only approved treatment in the US for paediatric patients living with the gMG.
Soliris® was approved for the same indication in the EU in July 2023.