26th Jun 2023 08:39
(Alliance News) - AstraZeneca PLC on Monday said Soliris has been recommended for marketing authorisation in the EU for expanded use in generalised myasthenia gravis, gMG.
The Cambridge-based pharmaceutical company said the treatment was recommended for approval for expanded use to include the treatment of refractory gMG in children and adolescents who anti-acetylcholine receptor, AChR, antibody-positive.
It was approved for certain adults with gMG back in 2017, and also holds approvals in the US, China and Japan.
"gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness," Astra explained.
It is caused by a defect in the action of acetylcholine at neuromuscular junctions.
Soliris, generically known as eculizumab, is a monoclonal antibody that targets protein C5 in the terminal complement cascade. The terminal complement cascade is a part of the body's immune system, which - when activated in an uncontrolled matter - can lead the body to attack healthy cells.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the treatment. If authorised, Soliris would be "the first and only targeted therapy" for paediatric patients age six plus with refractory gMG in the EU, Astra said.
Shares in AstraZeneca were down 0.2% at 11,404.00 pence each in London on Monday morning.
By Elizabeth Winter, Alliance News senior markets reporter
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