MHLW approves Alexion's Ultomiris (ravulizumab) for treatment of PNH adult patients

recently, Alexioncompany(http://announced that the Ministry of Health, Labour and Welfare (MHLW) has approved Ultomiris (ravulizumab) for the treatment of adult patients with haemoglobinuria (PNH)In the United States, Ultomiris was approved by theFDA(http://in December 2018 for treatment of adult patients with PNH, Ultomiris' application to treat adult patients with PNH is also being reviewed by EU regulatorsIn the United States, Japan and the European Union, Ultomiris has been granted an orphan drug for PNHabout Theof UltomirisUltomiris is a long-acting C5 supplement inhibitor that suppresses the C5 protein in the body's immune system complement cascade reactionThe drug is positioned as an upgraded version of Alexion's heavy-
drug(http://Soliris, which was first approved for market ingress in 2007 and has been approved for treatment of three rare diseases: PNH, atypical hemolytic uremic syndrome (aHUS), antiacetylcholine receptor antibody-positive systemic severe muscle weakness (gMG) in addition, Soliris' treatment of spinal cord itisis-optic neurospectral disorder (NMOSD) entered the FDA's priority review in late February 　The of the study is based on comprehensive data from two key Phase III clinical studies, the largest Phase III study ever conducted in PNH patients, with a total of 441 patients, including PNH patients who have never been treated with tonic inhibitors, and PNH patients who have received a stable condition of Soliris (eculizumab) data show that Ultomiris is not bad either every eight weeks and Soliris is in effect in all 11 ends (major and all key secondary ends) every 2 weeks studies, Ultomiris was similar to Soliris' security Recently released additional data show that Ultomiris provides immediate and complete C5 inhibition for 8 weeks, while eliminating breakthrough hemolytic associated with incomplete C5 inhibition