Bivv001 hemophilia
WebSemantic Scholar profile for K. Knockenhauer, with 91 highly influential citations and 40 scientific research papers. WebMar 11, 2024 · Paris and Stockholm – March 9, 2024 – Sanofi and Swedish Orphan Biovitrum AB  today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ≥12 years of age with severe hemophilia A.
Bivv001 hemophilia
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What is Altuviiio for hemophilia? Altuviiio (efanesoctocog alfa), previously known as BIVV001, is an approved long-lasting factor VIII (FVIII) replacement therapy for children and adults with hemophilia A.It is indicated as a prophylactic or preventive therapy to lower the frequency of bleeding episodes, and also can … See more Efanesoctocog alfa is based on Fc fusion technology, and is made by adding a region of a blood-clotting protein called von Willebrand factor (VWF) and a polypeptide … See more Sanofi and Sofi announced plans to begin filing applications to regulatory agencies in 2024 requesting that efanesoctocog alfa be approved to treat … See more In preclinical studies, the pharmacological properties of efanesoctocog alfa were found to be similar to those of recombinant FVIII (rFVIII). The … See more An open-label (no placebo group), dose-escalation Phase 1/2a study, called EXTEN-A (NCT03205163), investigated the safety, tolerability, and pharmacokinetics … See more WebNov 29, 2024 · BIVV001: The First Investigational Factor VIII Therapy to Break Through the VWF Ceiling in Hemophilia A, with Potential for Extended Protection for One Week or Longer. ... Low-dose BIVV001 demonstrated an extended half-life of 37.6 hours, compared with a 12.1-hour half-life for rFVIII. Average FVIII activity post-infusion of BIVV001 was …
WebSkip to topic navigation. Skip to main content. Conditions & Treatments. Adult Health Library. Allergy and Asthma WebMar 11, 2024 · These findings showed that BIVV001 could provide a high level of sustained factor VIII activity in patients with severe hemophilia A. Overall, single-dose BIVV001 …
WebApr 23, 2024 · BIVV001, or rFVIIIFc-VWF-XTEN, results from the fusion of BDD-FVIII with the D′D3 region of VWF, the Fc fragment of human IgG1 and 2 XTEN polypeptides. The engineered molecule lacks the capacity to bind endogenous VWF and has a prolonged half-life. ... Hemophilia A is a rare X-linked inherited hemorrhagic disorder resulting from … WebApr 22, 2024 · Executive Director. Jun 2024 - Jul 20243 years 2 months. Greater Boston Area. Program, Research and Biomarker lead (triple …
WebThis article summarizes the milestones in the development of efanesoctocog alfa leading to this first approval for hemophilia A. Efanesoctocog alfa (ALTUVIIIOTM; [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]), a von Willebrand factor (VWF) independent, recombinant DNA-derived Factor VIII (FVIII) concentrate, has been …
WebAug 30, 2024 · Paris and Stockholm – August 30, 2024 – The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February … mtb chainstayWebJun 1, 2024 · Paris and Stockholm – June 1, 2024 – The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of ... mtb challenging scholarshipWebApr 23, 2024 · BIVV001 is the first rFVIII with the potential to significantly change the treatment paradigm for severe hemophilia A by providing optimal protection against all … how to make onion paperWebMar 9, 2024 · Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment. ... (BIVV001) in previously treated patients ≥12 years of age with severe hemophilia A. The study met the primary endpoint, showing a clinically meaningful prevention of bleeds in … mtb chainringWebSkip to main content. MyChart Patient Portal; For Providers; Research; School of Medicine; Find care how to make onion juice with blenderWebNov 22, 2024 · The prevalence of Hemophilia B in the population is about one in 40,000; Hemophilia B represents about 15% of patients with hemophilia. Many women carriers of the disease have no symptoms. how to make onion powder from scratchWebApr 23, 2024 · BIVV001 is the first rFVIII with the potential to significantly change the treatment paradigm for severe hemophilia A by providing optimal protection against all … mtb change address