CHMP recommends approval of Alexion's ultomiris (ravulizumab) for the treatment of haemoglobinuria

recently, Alexion(http:// announcedthat the Europeanmedicines(http://Authority (
HTTP://WWW.CHEMDRUG.COM/)Product http://
sons and http:// (http://Committee (CHMP) has issued an active review recommending the approval of Ultomiris for the treatment of adult patients with haemoglobinuria (PNH)now, CHMP's opinion will be submitted to the European Commission (EC), which will refer to CHMP's opinion and make a final review decision in the next 2-3 monthsIn the United States, Ultomiris was approved by theFDA(http://in December 2018 for treatment of adult patients with PNHIt's worth noting that Alexion used a priority review voucher to speed up the drug's review in the United States, Ultomiris' application to treat adult patients with PNH is also under review by Japanese regulatorsIn both the United States and the European Union, Ultomiris has been granted an orphan drug for PNHAbout Ultomiris
Ultomiris 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 FebruaryThe studyCHMP recommended approval of Ultomiris, based on two key Phase III clinical studies, the largest Phase III study ever conducted in PNH patients, with a total of 441 patients, including those who had never received a tonic inhibitor and a stable PNH patient with Soliris (eeizumab)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 weeksstudies, Ultomiris was similar to Soliris' securityRecently released additional data show that Ultomiris provides immediate and complete C5 inhibition for 8 weeks, while eliminating breakthrough hemolytic associated with incomplete C5 inhibitionUltomiris's entire clinical development program to date represents more than 750 years of experience with patients