Soliris approved in China for the treatment of adults with neuromyelitis optica spectrum disorder. Alexion Pharma/AstraZeneca

Soliris is the first and only complement inhibitor approved for the treatment of NMOSD in China. The approval by the National Medical Products Administration (NMPA) in China was based on results from the Phase III PREVENT trial. In the trial, Soliris met the primary endpoint of prolonging the time to first adjudicated relapse and reducing the risk of relapse. At 48 weeks, 98 percent of patients treated with Soliris were relapse free compared to 63 percent of patients receiving placebo (relative risk reduction, 94.2%; hazard ratio=0.058; 95% CI: 0.017–0.197; p<0.0001).additionally, 96 percent of patients treated with soliris remained relapse free at 144 weeks during prevent compared to 45 percent of patients treated with placebo.></0.0001).additionally,>

Xu Yan, MD, PhD, Chief Physician of the Department of Neurology, Peking Union Medical College Hospital and Deputy Leader of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association, said: “The Phase III PREVENT trial established the safety and efficacy of C5 inhibition in reducing the frequency of relapses that can lead to severe and long-term disability for people living with NMOSD. With nearly all patients in the trial achieving relapse-free status at 48 weeks, today’s approval marks a fundamental shift in the care of NMOSD in China".