AstraZeneca Announces Approval of Soliris in China
Wednesday, June 14, 2023
AstraZeneca announced that Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Soliris is a first-in-class C5 complement inhibitor that works by inhibiting the C5 protein in the terminal complement cascade, a component of the body's immune system. By targeting this pathway, Soliris helps to control the uncontrolled activation of the complement system, which can lead to the body attacking its own healthy cells.
Soliris, a medication, has been granted approval by the National Medical Products Administration (NMPA) in China, based on the results obtained from the Phase III REGAIN trial. The trial provided comprehensive results showing the clinical benefit of Soliris for patients with anti-AChR antibody-positive generalised myasthenia gravis (gMG). These patients had previously not responded to immunosuppressive treatment and still experiencing significant unresolved symptoms of the disease.
Soliris has been approved in several countries, including the United States, European Union, Japan, and China, for the treatment of various conditions.
The approval of Soliris marks a significant milestone for the generalised myasthenia gravis (gMG) community in China, providing with a targeted treatment option that has substantial clinical data and extensive real-world evidence which improves the ability to carry out daily activities and enhances the overall quality of life for patients.
