UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG) who test positive for anti-Acetylcholine receptor (AChR) antibodies.
The Role of the Complement System and Soliris’ Mechanism
The human immune system includes the complement system, which plays a crucial role in fighting infections. However, uncontrolled activation of the complement system can lead to the body attacking its own healthy cells. Soliris has been previously approved in the US, European Union (EU), Japan, and China for conditions such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremia syndrome (HUS), and specific generalized Myasthenia gravis (gMG), as well as specific neuromyelitis optica spectrum disorders (NMOSD) in the US, EU, and Japan.
Soliris’ Market Approvals in China
Soliris was approved for use in China in September 2018 for the treatment of PNH and HUS. The latest approval for refractory gMG expands the drug’s therapeutic applications in the country, providing an additional treatment option for patients suffering from this debilitating neuromuscular disease.-Fineline Info & Tech
