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Under the collaboration, RoslinCT will manufacture the world’s first CRISPR-based therapy, exa-cel (exagamglogene autotemcel), a new treatment for sickle cell disease and transfusion-dependent beta thalassemia, across the world for Vertex.
Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) used for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.
Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.
Studies demonstrated that Duvroq (daprodustat) improved or maintained Hb within target level, and primary safety analysis of populations showed that daprodustat achieved non-inferiority of MACE compared to standard of care, both non-dialysis and dialysis patient settings.
Coagadex® is the first and only treatment specifically for Hereditary Factor X Deficiency, a very rare inherited clotting disorder that causes problems with blood clotting due to not having enough Factor X in the blood.
Ondexxya is the first approved medicine in Japan to specifically reverse the anticoagulant effect of FXa inhibitors apixaban, rivaroxaban or edoxaban in patients experiencing a life-threatening or uncontrolled bleed.
The MAA based on positive data from ASCEND Phase III clinical trial programme for GSK1278863 (daprodustat), a HIF-PHI met co-primary efficacy and safety endpoints also, approved in Japan as Duvroq for patients with renal anaemia.
GSK1278863 (Daprodustat) is first oral HIF-PHI to clearly show positive efficacy, along with no increased cardiovascular risk as assessed in primary analysis. Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia.
Approval of Ultomiris is based on interim results from Phase III trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to Soliris.