WebFeb 18, 2024 · Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential to transform therapy and provide … WebApr 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 …
BIVV001 Safely Treats Severe Hemophilia A as Weekly Injection...
WebFeb 18, 2024 · Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (XTEND-Kids) The safety and scientific validity of this study is the responsibility of the … 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 … css re01
Global Hemophilia A Pipeline Insights Clinical Trials
WebSep 29, 2024 · BIVV001 is an investigational once-weekly haemophilia A replacement therapy with the potential to deliver a new standard of care in personalised treatment. BIVV001 phase 3 pivotal trial anticipated to start later this year. As part of the extended Sanofi agreement, a new supply agreement now in place until 2027. WebJan 9, 2024 · by Alejandra Viviescas, PhD January 9, 2024. A single dose of BIVV001 significantly increased levels of factor VIII for a week in the blood of people with severe hemophilia A, according to early results of a Phase 1/2a study. The treatment increased the half-life of factor VIII to 44 hours and showed no side effects or development of inhibitors. 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 css react box