MHLW approves Alexion's Soliris (eculizumab) for a new indication

Recently, Alexioncompany(http:// announcedthat the Ministry of Health, Labour and Welfare (MHLW) has approved a new indication of Soliris (eculizumab) for the treatment of anti-water channel protein-4 (AQP4) antibody-positive psyroidal spinal cord inflammation disorder (NMOSD, including optic neurospinal itisen) patients to prevent recurrenceIn the United States and the European Union, Soliris was approved in June and August this year to treat patients with anti-AQP4 antibody-positive NMOSD, the drug is also the firstdrug approved in the United States and Europe to treat NMOSD
(http://In the United States, the European Union and Japan, Soliris has been granted the Orphan Drug (ODD) for the treatment of NMOSD patientsSoliris is a pioneering complement inhibitor that works by inhibiting the C5 protein in the end part of the complement cascade reactionComplementary cascades are part of the immune system and their uncontrolled activation plays an important role in severe rare and super-rare diseases, including: intermittent sleephetinhetinuria (PNH), atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive severe muscle weakness (MG), and NMOSDThe studySoliris New Indications Approved, based on data from Phase III clinical study PREVENTThe study was conducted in patients with anti-AQP4 autoantibody-positive NMOSD and assessed the efficacy and safety of Soliris relative to placeboThe results showed that the study reached its primary endpoint, with Soliris significantly reducing the risk of NMOSD recurrence by 94.2% (p0.0001) compared to placeboAt the 48th week of treatment, 97.9% of patients in the Soliris treatment group did not relapse, compared with 63.2% in the placebo groupIn addition, Soliris significantly reduced the annual recurrence rate during the study period by 95.5% (p.0.0001) compared to the placebo, reaching the key secondary endpoint of the study 　　In the study, Soliris was well tolerated and safe in line with previous studies and actual clinical practice in the three indications approved in the real world