Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi 
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 0 Diseases   8 Trials   8 Trials   273 News 


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  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Review, Journal:  Plasma Clearance of Coagulation Factor VIII and Extension of Its Half-Life for the Therapy of Hemophilia A: A Critical Review of the Current State of Research and Practice. (Pubmed Central) -  May 31, 2023   
    We focus on the EHL FVIII products' structure and function, in particular related to the known discrepancy in results of one-stage clotting (OC) and chromogenic substrate (CS) assays used to assign the products' potency, dosing, and for clinical monitoring in plasma. We suggest a possible root cause of these assays' discrepancy that is also pertinent to EHL factor IX variants used to treat hemophilia B. Finally, we discuss approaches in designing future EHL FVIII variants, including those to be used for hemophilia A gene therapy.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Review, Journal:  Efanesoctocog Alfa: First Approval. (Pubmed Central) -  May 22, 2023   
    Efanesoctocog alfa was approved in February 2023 in the USA for use in adults and children with hemophilia A (congenital FVIII deficiency) for: routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; perioperative management of bleeding. This article summarizes the milestones in the development of efanesoctocog alfa leading to this first approval for hemophilia A.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Journal:  Altuviiio - a longer-acting factor VIII product for hemophilia A. (Pubmed Central) -  May 12, 2023   
    This article summarizes the milestones in the development of efanesoctocog alfa leading to this first approval for hemophilia A. No abstract available
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Now it will be Altuviiio 😊 (Twitter) -  Feb 23, 2023   
  • ||||||||||  Altuviiio (efanesoctocog alfa) / SOBI, Sanofi
    TREATMENT OF BLEEDING EPISODES WITH EFANESOCTOCOG ALFA IN PATIENTS WITH SEVERE HAEMOPHILIA A IN THE PHASE 3 XTEND-1 STUDY () -  Feb 13, 2023 - Abstract #EAHAD2023EAHAD_438;    
    P3
    Once-weekly prophylaxis with efanesoctocog alfa showed meaningful improvement in pain and physical functioning in patients with severe haemophilia A. The exit interviews also highlighted additional benefits such as less fatigue and improved health related quality of life. A single 50 IU/kg dose of efanesoctocog alfa effectively treated 96.7% of BEs regardless of bleed type and location in patients receiving prophylaxis or on-demand treatment.
  • ||||||||||  Altuviiio (efanesoctocog alfa) / SOBI, Sanofi
    EFANESOCTOCOG ALFA PROPHYLAXIS IMPROVES HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH HEMOPHILIA A: RESULTS FROM THE XTEND-1 PHASE 3 STUDY () -  Feb 13, 2023 - Abstract #EAHAD2023EAHAD_386;    
    P3
    A single 50 IU/kg dose of efanesoctocog alfa effectively treated 96.7% of BEs regardless of bleed type and location in patients receiving prophylaxis or on-demand treatment. Associated with prevention of bleeds, significant improvements in HRQoL were shown in PwHA switching from prior FVIII prophylaxis to efanesoctocog alfa prophylaxis, potentially bringing PwHA closer to a HRQoL of the non-hemophilic population.Funding: Sanofi/Sobi
  • ||||||||||  Altuviiio (efanesoctocog alfa) / SOBI, Sanofi
    PERIOPERATIVE MANAGEMENT WITH EFANESOCTOCOG ALFA IN PATIENTS WITH HEMOPHILIA A IN THE PHASE 3 XTEND-1 STUDY () -  Feb 13, 2023 - Abstract #EAHAD2023EAHAD_359;    
    P3
    Efanesoctocog alfa was effective and well tolerated for the perioperative management of adults/adolescents with severe hemophilia A who underwent major surgery in XTEND-1. One preoperative efanesoctocog alfa injection was sufficient for the duration of surgery and all hemostatic responses were rated as excellent.
  • ||||||||||  Altuviiio (efanesoctocog alfa) / SOBI, Sanofi
    Journal:  Efanesoctocog Alfa Prophylaxis for Patients with Severe Hemophilia A. (Pubmed Central) -  Feb 1, 2023   
    P3
    In patients with severe hemophilia A, once-weekly efanesoctocog alfa provided superior bleeding prevention to prestudy prophylaxis, normal to near-normal factor VIII activity, and improvements in physical health, pain, and joint health. (Funded by Sanofi and Sobi; XTEND-1 ClinicalTrials.gov number, NCT04161495.).
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Trial completion:  XTEND-Kids: Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (clinicaltrials.gov) -  Jan 23, 2023   
    P3,  N=75, Completed, 
    (Funded by Sanofi and Sobi; XTEND-1 ClinicalTrials.gov number, NCT04161495.). Active, not recruiting --> Completed
  • ||||||||||  Altuviiio (efanesoctocog alfa) / SOBI, Sanofi
    Efficacy of Efanesoctocog Alfa on Physical Functioning: Results from the XTEND-1 Phase 3 Clinical Trial in Previously Treated Patients with Hemophilia A (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_3883;    
    P3
    Pain is an important burden in patients with severe hemophilia A. Once-weekly prophylaxis with efanesoctocog alfa resulted in improvement in reduction of pain in patients with severe hemophilia A, when switching from prophylaxis with standard of care FVIII therapies to efanesoctocog alfa. Once-weekly prophylaxis with efanesoctocog alfa resulted in improvement in physical functioning in patients with hemophilia A, positively impacting daily living activities, in patients who were on prior standard of care FVIII prophylaxis.
  • ||||||||||  efanesoctocog alfa (BIVV001) / SOBI, Sanofi
    P1 data, Journal:  Efanesoctocog alfa for hemophilia A: results from a phase 1 repeat-dose study. (Pubmed Central) -  Apr 27, 2022   
    Overall, four once-weekly doses of efanesoctocog alfa were well tolerated, no safety concerns identified, and no bleeds reported during the treatment period. Once-weekly efanesoctocog alfa provided high sustained FVIII activity within the normal to near-normal range for 3-4 days post-dose and may improve protection against bleeds in patients with hemophilia A. (EU Clinical Trials Register study 2018-001535-51).
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Trial completion date, Trial primary completion date:  To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (clinicaltrials.gov) -  Apr 12, 2022   
    P1,  N=9, Recruiting, 
    Once-weekly efanesoctocog alfa provided high sustained FVIII activity within the normal to near-normal range for 3-4 days post-dose and may improve protection against bleeds in patients with hemophilia A. (EU Clinical Trials Register study 2018-001535-51). Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
  • ||||||||||  efanesoctocog alfa (BIVV001) / SOBI, Sanofi
    PROPHYLAXIS AND ZERO BLEED FOR ALL ADULT PATIENTS WITH SEVERE HEMOPHILIA: AN ACHIEVABLE AMBITION WITH NEW TREATMENT OPTIONS ([VIRTUAL]) -  Jan 28, 2022 - Abstract #EAHAD2022EAHAD_296;    
    After treatment adaptation, 97 out of 99 non-inhibitor patients were on prophylaxis with SHL-FVIII (16), EHL-FVIII (23), EHL-FIX (18), bispecific antibody (n = 40), BIVV001 (n = 2)... In our experience, the wide range of current treatment options as well as the multidisciplinary selection of a personalized treatment modality allowed to achieve the adoption of and adherence to a highly effective prophylaxis in nearly all adult patients with severe HA or HB.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Enrollment closed:  XTEND-Kids: Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (clinicaltrials.gov) -  Jan 26, 2022   
    P3,  N=68, Active, not recruiting, 
    In our experience, the wide range of current treatment options as well as the multidisciplinary selection of a personalized treatment modality allowed to achieve the adoption of and adherence to a highly effective prophylaxis in nearly all adult patients with severe HA or HB. Recruiting --> Active, not recruiting
  • ||||||||||  efanesoctocog alfa (BIVV001) / SOBI, Sanofi
    Journal:  Molecular determinants of the factor VIII/von Willebrand factor complex revealed by BIVV001 cryo-electron microscopy. (Pubmed Central) -  Dec 16, 2021   
    Our structure shows direct interaction of sulfated Y1680 in FVIII-a3 and VWF-R816, which, when mutated, leads to severe hemophilia A or VWD type 2N, respectively. These results provide insight on this key coagulation complex, explain the structural basis of many hemophilia A and VWD type 2N mutations, and inform studies to further elucidate how VWF dissociates rapidly from FVIII upon activation.