European Commission approves Ultomiris ® (ravulizumab) for treatment of adult patients with haemoglobinuria
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Alexion Pharmaceuticals announced that the European Commission has approved the Ultomiris ® for the treatment of adult patients with haemoglobinuriaon theof Ultomiris
Ultomiris is a long-acting C5 supplement inhibitor that suppresses the C5 protein in the body's immune system complement cascade reactionUltomiris is positioned as an upgraded version of Alexion(http://heavy-weightdrug(http://Soliris, which was first approved for market ingress in 2007 and has been approved for treatment of three rare diseases: PNH, atypical hemolytic urethra syndrome (aHUS), antiacetylcholine receptor-positive systemic severe muscle weakness (gMG)In the United States, Ultomiris was approved by theFDA(http://in December 2018 for treatment of adult patients with haemoglobinuriaIt is worth noting that Alexion used the priority review channel to expedite the drug's review in the United Statesin June, Ultomiris also received approval from the Japanese authorities It is worth mentioning that in the United States, Japan and the European Union, Ultomiris has been granted the orphan drug status related studies this approval, based on two key Phase III clinical studies, this is the largest phase III study ever conducted in patients with haemophilic hemoglobin urination, a total of 441 patients, including those who have never been treated with a tonic inhibitor (initial treatment) of haemoglobinuria, and patients with a stable formof hemoglobin patients with 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 Ultomiris' entire clinical development program to date represents more than 800 patient years of experience
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