FDA approves Alexion's long-acting C5 tonic inhibitor Ultromiris (ravulizumab-cwvz) extended indications
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Alexion Pharmaceuticals(http:// announcedthat the U.SFDA(http://approved the company's long-acting C5 tonic inhibitor Ultromiris (ravulizumab-cwvz) extended indications for the treatment of atypical hemolytic uremic syndrome (aHUS) patients (aHUS) patients (more than one month old) to complement the tonic-mediated thrombosis (TAM)About Ultomiris
Ultomiris is a long-acting C5 tonic inhibitor developed by Alexion that inhibits the activation of the complement signal ingress signal path by inhibiting the effect protein C5 of the complement-level connectivity pathPatients need only receive an injection every 8 weeks to effectively inhibit the activation of the complement signaling pathwayUltomiris has received FDA approval to treat haemoglobinuria (PNH)The approval is based on the results of two global, single-arm open label studies, including an adult clinicaltrial(http://and a clinical trial in pediatric patientsThe results showed that 54% of adult sand patients and 71% of children in adult patients developed complete remission of thrombosis microvascular disease (TAM) after the initial 26-week course of treatmentFurthermore, Ultomiris reduced thrombocytopenia in 84% of adults and 93% of children, hemolytic in 77% of adults and 86% of children, and improved kidney function in 59% of adults and 79% of children (data for children are medium-term)
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