AstraZeneca announced that the Chinese NMPA has approved Soliris® (eculizumab) for treatment of refractory generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This is the third approved indication approved for Soliris® in China, and is the first and only complement inhibitor approved to treat gMG in China. The NMPA’s approval was based on results of the Phase III REGAIN trial in which Soliris® demonstrated clinical benefit for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and suffered significant unresolved disease symptoms.
Biosimilars to Soliris® are in the pipeline: on 30 May 2023 Samsung Bioepis’ Epysqli® (eculizumab) was approved in Europe to treat paroxysmal nocturnal hemoglobinuria, and on 23 February 2023 the CHMP recommended MA for Amgen’s Bekemv® for the same condition.
Print Page Mail Article