Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi 
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  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    PK/PD data, Journal:  Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time-To-Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A. (Pubmed Central) -  Jun 26, 2025   
    P1/2, P3
    Bleeding episodes in participants in XTEND-1 and XTEND-Kids were characterized by an RTTE model with a Weibull base hazard and effect of FVIII activity modeled by a power effect. The RTTE model showed the probability of being bleed-free in 1 year with efanesoctocog alfa 50 IU/kg QW regimen was >70% across all age groups, consistent with the observed clinical outcomes in the Phase 3 trials of highly effective protection from bleeding episodes in patients with severe hemophilia A, which validates the model's prediction of the long-term bleed hazard.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Journal:  Altuvoct: Innovative Medicinal Products Benefit from Innovative Approaches to Regulatory Assessment. (Pubmed Central) -  Jun 26, 2025   
    Data from two single-arm ongoing studies were submitted: the XTEND-1 study enrolled 159 subjects aged 12-72 years, and the XTEND-kids study enrolled 74 subjects aged <12 years; all subjects had severe haemophilia A. Single-arm studies are not amenable to conventional statistical analysis of 'effect of cause', and so a supplementary analysis was conducted on the basis of 'cause of effect', making use of the scheme described by Toulmin coupled to an analysis of causal inference. Overall, the claim that Altuvoct is indicated to treat people aged ?2 years with severe (and moderate) haemophilia A was considered to be supported by the results of the submitted studies and associated modelling exercises; the benefit-risk evaluation of Altuvoct was found to be positive in the target population.
  • ||||||||||  PHYSICIANS OPTIMISTIC ABOUT NEXT EVOLUTION IN HEMOPHILIA PATIENT CARE () -  May 15, 2025 - Abstract #EHA2025EHA_3659;    
    Newer options are providing better efficacy for different patient types and with favorable administration. As these options are approved and launched, hematologists expect many patients will be candidates and they will quickly begin prescribing these agents as appropriate to improve patient quality of care.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi, Esperoct (antihemophilic factor (recombinant), glycopegylated-exei) / Novo Nordisk, Jivi (damoctocog alfa pegol) / Bayer
    CHATGPT4O () -  May 15, 2025 - Abstract #EHA2025EHA_3649;    
    As these options are approved and launched, hematologists expect many patients will be candidates and they will quickly begin prescribing these agents as appropriate to improve patient quality of care. Within the VIII factors of extended half-life, Esperoct
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Review, Journal:  Haemophilia Prophylaxis in the Age of Innovation: Exploring Opportunities for Personalized Treatment. (Pubmed Central) -  Apr 17, 2025   
    Ongoing research and real-world studies are essential to assess long-term efficacy and safety. In addition, improving educational resources-such as digital platforms, virtual reality tools and personalized educational materials tailored to patients' life goals-and effective patient engagement strategies will be critical to achieving successful treatment personalization and adherence.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    P3 data, Journal:  Treatment of Bleeding Episodes With Efanesoctocog Alfa in (Pubmed Central) -  Apr 3, 2025   
    P3
    Median total dose was 50.9?IU/kg per bleeding episode. Results of this analysis further demonstrated that once-weekly efanesoctocog alfa provides highly effective bleed protection and treatment of bleeding episodes in participants with severe hemophilia A. Trial Registration: NCT04161495.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Review, Journal:  Efanesoctocog Alfa Versus Emicizumab in Adolescent and Adult Patients With Haemophilia (Pubmed Central) -  Jan 30, 2025   
    P3
    Patients had, on average, 2.2 and 3.6 fewer bleeds per year versus EHL and SHL therapies, respectively. Efanesoctocog alfa prophylaxis was associated with significantly lower rates of any, treated, and joint bleeds and improved joint health compared with emicizumab in patients with severe haemophilia
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche, Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Journal:  Accurate evaluation of factor VIII activity of efanesoctocog alfa in the presence of emicizumab. (Pubmed Central) -  Jan 12, 2025   
    Efanesoctocog alfa prophylaxis was associated with significantly lower rates of any, treated, and joint bleeds and improved joint health compared with emicizumab in patients with severe haemophilia Specific calibration of the CSA FVIII assay using efanesoctocog and bovine reagents allows for accurate measurement of FVIII activity in patients receiving efanesoctocog, even in the presence of emicizumab.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    PK/PD data, Review, Journal:  Pharmacokinetic evaluation of efanesoctocog alfa: breakthrough factor VIII therapy for hemophilia A. (Pubmed Central) -  Jan 3, 2025   
    Efanesoctocog alfa with outstanding pharmacological properties, well tolerated in the clinical trials, is a promising FVIII therapy for PwHA. Future studies should include long-term safety especially in previously untreated patients.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    P3 data, Journal, Interview:  Patient Experience With Efanesoctocog Alfa for Severe Hemophilia A: Results From the XTEND-1 Phase 3 Clinical Study Exit Interviews. (Pubmed Central) -  Dec 12, 2024   
    P3
    The exit interviews demonstrated that once-weekly efanesoctocog alfa prophylaxis resulted in patient-relevant and meaningful improvements in pain and physical functioning, consistent with the quantitative findings from XTEND-1. These results support the validity of the Haem-A-QoL PH and PROMIS Pain Intensity 3a assessed during XTEND-1, demonstrating the potential for change with efficacious treatment.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche, Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Real-World Patterns of Additional Factor Treatment Use Among Hemophilia a Patients on Regular Prophylaxis in the United States: Results from the Picnichealth Database (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_4708;    
    Background The standard-of-care for hemophilia A (HA) involves prophylaxis (PPX) with factor replacement therapies (standard half-life [SHL] and extended half-life [EHL]), or emicizumab (Emi)...Patients with evidence of mild HA (6%?50%), any FVIII inhibitor (on index), or treated with efanesoctocog alfa were excluded...Among Emi PPX users, 62% on weekly regimen, 64% on biweekly regimen, and 36% on monthly regimen used additional factor treatment. Conclusion The majority of patients with moderate or severe HA on routine PPX use additional factor treatments to treat bleeds, whereas a smaller proportion of patients use additional factor treatment before physical activity or procedures to prevent bleeds.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / Sanofi
    Association between Hemophilia Joint Health Score and Quality of Life Using Results from the Xtend-1 Efanesoctocog Alfa Phase 3 Trial (Room 30 (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1901;    
    P3
    LS mean difference (95% confidence interval) between QoL PROs CFB at Week 52 in "Maintenance or improvement" and "Worsening" HJHS subgroups were : PROMIS Pain Intensity worst score -0.61 (?1.17 to -0.05; p=0.032), PROMIS Pain Intensity T-score -3.79 (-7.56 to -0.02; p=0.049), Haem-A-QoL total score -6.21 (-12.38 to -0.05; p=0.048), Haem-A-QoL PH score -2.65 (-4.63 to -0.67; p=0.009), and PROMIS PF T-score 3.34 (5.99 to 0.69; p=0.014). Conclusion Our findings indicate a stronger improvement in PROs across the three domains of pain, physical functioning, and overall QoL, in patients with joint improvement or maintenance compared with patients with joint worsening, thus highlighting the importance of improved or preserved joint health in patients with hemophilia A. Prospective validation is warranted to confirm these data.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Journal:  Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A. (Pubmed Central) -  Jul 17, 2024   
    P3
    Efanesoctocog alfa was associated with mainly nonserious adverse events. (Funded by Sanofi and Sobi; XTEND-Kids ClinicalTrials.gov number, NCT04759131.).
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Review, Journal:  "Ultra-Long FVIII: A Major Step Forward to a Hemophilia-Free Mind". (Pubmed Central) -  Jun 30, 2024   
    Leveraging expertise gained with fusion to immunoglobulin Fc fragments, disconnecting FVIII from endogenous von Willebrand factor (via a D'-D3 fragment), and benefiting from the pharmacokinetic prolongation provided by the addition of hydrophilic polypeptides, efanesoctocog alfa opens a new era in the treatment of hemophilia A. The term Ultra-Long (UL) FVIII has been proposed to designate it and differentiate it from EHL FVIII. The level of FVIII correction within the normal range for several days provided by this molecule should allow an increasing number of patients to mentally and physically free themselves from the physical and psychological constraints of hemophilia A. Certainly, the constraint of weekly intravenous infusions persists, but is compensated by a correction of hemostasis whose amplitude and duration remain unmatched by other therapeutic options currently available.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Journal:  Practical challenges associated with efanesoctocog alfa (ALTUVIIIO) prophylaxis in a 19-month-old male with severe hemophilia A. (Pubmed Central) -  Jun 26, 2024   
    The level of FVIII correction within the normal range for several days provided by this molecule should allow an increasing number of patients to mentally and physically free themselves from the physical and psychological constraints of hemophilia A. Certainly, the constraint of weekly intravenous infusions persists, but is compensated by a correction of hemostasis whose amplitude and duration remain unmatched by other therapeutic options currently available. No abstract available
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Pediatric Perspective: A Clinical Discussion on ALTUVIIIO for Kids (Theater 1, Queen Sirikit National Convention Center, Bangkok, Thailand) -  May 18, 2024 - Abstract #ISTH2024ISTH_2432;    
    Recruiting --> Active, not recruiting Sponsored by Sanofi
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Achieving More Days Near Normal with ALTUVIIIO (Theater 1, Queen Sirikit National Convention Center, Bangkok, Thailand) -  May 18, 2024 - Abstract #ISTH2024ISTH_2431;    
    Sponsored by Sanofi Sponsored by Sanofi
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi, Adynovate (rurioctocog alfa pegol) / Takeda, Advate (octocog alfa) / Takeda
    INDIVIDUAL PHARMACOKINETIC EVALUATION OF FIXED-SEQUENCE SINGLE-DOSE OCTOCOG ALFA, RURIOCTOCOG ALFA PEGOL, AND EFANESOCTOCOG ALFA IN ADULTS WITH SEVERE HEMOPHILIA A (Sheraton Ballroom I-II; Virtual) -  Mar 2, 2024 - Abstract #THSNA2024THSNA_301;    
    P1
    No TEAEs were serious, led to treatment discontinuation, or were deemed related to efanesoctocog alfa treatment.ConclusionConsistent superiority regarding time over 40% FVIII activity, half-life, clearance, and FVIII exposure were observed with efanesoctocog alfa compared with SHL and EHL FVIII in all patients. No serious TEAEs or inhibitor development were reported for efanesoctocog alfa.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    OUTCOMES IN NORTH AMERICAN PARTICIPANTS WHO RECEIVED EFANESOCTOCOG ALFA PROPHYLAXIS IN THE XTEND-1 STUDY (Riverwalk AB; Virtual) -  Mar 2, 2024 - Abstract #THSNA2024THSNA_243;    
    P3
    Outcomes reported in this subset of participants from North America are similar to those observed in the overall population of XTEND-1. Once-weekly efanesoctocog alfa prophylaxis provided improved bleed protection compared with prior standard-of-care prophylaxis, with improvements in physical health, pain, and joint health.
  • ||||||||||  Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
    Journal:  Efanesoctocog alfa: the renaissance of Factor VIII replacement therapy. (Pubmed Central) -  Feb 15, 2024   
    The discussion extends beyond regulatory approval to encompass the preclinical and clinical development of efanesoctocog alfa, including considerations for laboratory monitoring. The review also highlights areas that warrant further investigation to deepen our understanding of this groundbreaking therapeutic agent.