The European Medicines Agency’s committee for medicinal products for human use (CHMP) has issued a positive opinion recommending marketing authorisation for expanded use of AstraZeneca’s Soliris (eculizumab).
The expanded indication is intended for the treatment of refractory generalised myasthenia gravis (gMG) in anti-acetylcholine receptor antibody-positive children and adolescents aged six to 17 years.
On obtaining marketing authorisation in the European Union (EU), the therapy will become the first to treat patients of this age group with refractory gMG in the region.
The latest development is based on data from the Phase III clinical trial of Soliris in paediatric subjects with refractory gMG.
Soliris demonstrated clinical benefit in those aged six years and above who were unresponsive to immunosuppressive therapy and had substantial unresolved symptoms.
Submissions to a range of regulatory authorities for Soliris usage in the paediatric population are currently underway, or at the planning stage.
AstraZeneca’s subsidiary Alexion CEO Marc Dunoyer stated: “If approved, Soliris would be the first targeted treatment for paediatric patients living with refractory gMG in Europe, offering the possibility of improved outcomes and quality of life.”
Soliris first obtained approval in the EU in 2017 to treat adults.
The latest development comes after China’s National Medical Products Administration approved the drug for refractory gMG in adults.