This site uses cookies to simplify and improve your online experience.  You can find out more about cookies and how you can disable them by reading our Terms and Conditions. By continuing to browse this site you agree to our use of cookies on this device.

Close
Roche Navigation Menu Roche Resources : Roche Resources
  • Sign in
  • Logout
  • Search
Roche
  • Up
  • Home
  • Search
  • Close search

						
							

Searching

    • Home
    • Roche Medicines
      Roche Medicines Overview
      • Oncology
      • Avastin® (bevacizumab)
      • Kadcyla® (trastuzumab emtansine)
      • PERJETA® (pertuzumab)
      • PHESGO®▼(pertuzumab/trastuzumab)
      • TECENTRIQ®▼ (atezolizumab)
      • Rozlytrek▼(entrectinib)
      • Neuroscience
      • OCREVUS®▼ (ocrelizumab)
      • Immunology
      • RoACTEMRA® (tocilizumab)
      • Haematology
      • Gazyvaro® (obinutuzumab)
      • POLIVY®▼ (polatuzumab vedotin)
      • Rare Diseases
      • HEMLIBRA®▼ (emicizumab)
    • Therapy Areas
      Therapy Areas Overview
      • Oncology
      • Breast Cancer
      • Haematology
      • Haematology
      • Neuroscience
      • Neuroscience
    • Congress and Meetings
      Congress and Meetings Overview
    • HCP Materials
      HCP Materials Overview
    • FAQs
      FAQs Overview
    • Prescribing Information
      Prescribing Information Overview
      • Find out more about:
      • ALECENSA®▼(alectinib)
      • Avastin® (bevacizumab)
      • Esbriet® (pirfenidone)
      • GAZYVARO® (obinutuzumab)
      • HEMLIBRA®▼(emicizumab)
      • Herceptin® (trastuzumab) IV
      • Herceptin® (trastuzumab) SC
      • Kadcyla® (trastuzumab emtansine)
      • OCREVUS®▼ (ocrelizumab)
      • Perjeta® (pertuzumab)
      • Phesgo®▼(pertuzumab/trastuzumab)
      • Polivy®▼(polatuzumab vedotin)
      • RoACTEMRA® (tocilizumab) RA/GCA
      • RoACTEMRA® (tocilizumab) pJIA/sJIA
      • RoACTEMRA® (tocilizumab) CRS
      • Rozlytrek® ▼(entrectinib)
      • Tecentriq®▼ (atezolizumab) HCC
      • Tecentriq®▼ (atezolizumab) Lung Cancer
      • Tecentriq®▼ (atezolizumab) mTNBC
      • Tecentriq®▼ (atezolizumab) mUC
    • Adverse Events Reporting
      Adverse Events Reporting Overview
    Close

    1 - of results for ""

    No results

    This website is intended for healthcare professionals (HCPs) only. If you are an HCP, register free to access the full content.

    HEMLIBRA

     

     

    For routine prophylaxis of bleeding episodes in patients of all ages with congenital haemophilia A, classified as severe or with Factor VIII (FVIII) inhibitors1

    • HEMLIBRA®▼ (emicizumab)
    • Prescribing Info
    • Efficacy
      • Efficacy RCTs
      • Efficacy Non-RCTs
      • Study Designs
    • Safety
      • Pharmacovigilance
    • Dosing
    • PK and MOA
    • Publications
    • Surgery
      • Minor Surgery
      • Major Surgery
    • Lab Assays
      • Haemophilia A and Laboratory Tests
    • Horizons Meetings
    • More
      • Prescribing Info
      • Efficacy
      • Safety
      • Dosing
      • PK and MOA
      • Publications
      • Surgery
      • Lab Assays
      • Horizons Meetings

    You are here:

    1. Roche Medicines
    2. Rare Diseases
    3. HEMLIBRA®▼ (emicizumab)
    4. Efficacy
    5. Efficacy RCTs
    Proven efficacy in congenital haemophilia A, classified as severe or with FVIII inhibitors

    HAVEN 1 and HAVEN 3 are randomised, multicentre, open label, phase III clinical trials in patients with congenital haemophilia A.

    Related links:

    • Long-term efficacy
    • Efficacy non-RCTs
    • Study designs
    • Pharmacokinetics and MOA

    HAVEN 3 demonstrated significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. episodic FVIII2

    HAVEN 3 was a randomised, multicentre, open-label, phase III study in 152 adult and adolescent males with severe congenital haemophilia A (endogenous FVIII activity, <1%) without inhibitors, ≥12 years; treated with episodic FVIII or FVIII prophylaxis in the prior 24 weeks.2,3

    Haven 3 Graph

    In the HAVEN 3 study, treated annualised bleed rate (ABR; primary efficacy endpoint) was 38.2 with episodic FVIII (95% CI, 22.9–63.8; Arm C, n=18) compared with:2

    • 1.5 with HEMLIBRA 1.5 mg/kg/QW, a 96% reduction (95% CI, 0.9–2.5; Arm A, n=36; p<0.001)
    • 1.3 with HEMLIBRA 3.0 mg/kg/Q2W, a 97% reduction (95% CI, 0.8–2.3; Arm B, n=35; p<0.001)
    Percentage of patients with zero treated bleeds

    56% and 60% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 0–18; Arm A, n=20/36) and HEMLIBRA Q2W (95% CI, 42–76; Arm B, n=21/35) vs. 0% with episodic FVIII (95% CI, 0–18; Arm C, n=0/18).2

    Significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. prior FVIII prophylaxis (intra-individual comparison of patients from non-interventional study, Arm D)2

    Haven 3 Graph - 68 Reduction treated ABR

    Treated ABR was 4.8 with prior FVIII prophylaxis (95% CI, 3.2–7.1) compared with:2

    • 1.5 with HEMLIBRA 1.5 mg/kg/QW, a 68% reduction (95% CI, 1.0–2.3; Arm D, n=48; risk ratio 0.32; 95% CI, 0.20–0.51; p<0.001)
    54% of patients had zero treated bleeds vs. 40% with prior FVIII prophylaxis.

    54% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 39–69; n=26/48) vs. 40% with prior FVIII prophylaxis (95% CI, 26–55; Arm D, n=19/48).2

    For further details of the intra-individual study please see  Study designs

    For full study details please refer to the  HAVEN 3 publication

    HAVEN 1 demonstrated significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. episodic bypassing agents (BPAs)4

    HAVEN 1 was a randomised, multicentre, open-label, phase III study in 109 adult and adolescent males with congenital haemophilia A with FVIII inhibitors ≥12 years, ≥40 kg; treated with episodic BPAs or BPA prophylaxis in the prior 24 weeks.4,5

    Haven 1 Graph. 87% Reduction

    In HAVEN 1, treated ABR (primary efficacy endpoint) was 23.3 with episodic BPAs (95% CI, 12.3–43.9, Arm B, n=18) compared with:4

    • 2.9 with HEMLIBRA 1.5 mg/kg/QW, an 87% reduction (95% CI, 1.7–5.0; Arm A, n=35; p<0.001)
    Haven 1 Graph - 62.9% reduction of patients had zero treated bleeds vs 5.6% with episodic BPA's

    62.9% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 44.9–78.5; Arm A, n=22/35) vs. 5.6% with episodic BPAs (95% CI, 0.1–27.3; Arm B, n=1/18).4,5

    For details on how efficacy is maintained over time please see Long-term efficacy

    For details of the HAVEN 2 and HAVEN 4 non-randomised trials please see Efficacy non-RCTs

    For details on safety please see Safety

    For full study details please refer to the  HAVEN 1 publication

    ABR, annualised bleed rate; BPA, bypassing agent; CI, confidence interval; FVIII, Factor VIII; QW, every week; Q2W, every 2 weeks; RCT, randomised controlled trial.

    References:

    1. HEMLIBRA Summary of Product Characteristics.
    2. Mahlangu J et al. N Eng J Med 2018;379:811–22.
    3. Mahlangu J et al. N Eng J Med 2018;379:811–22 [Supplementary Appendix].
    4. Oldenburg J et al. N Eng J Med 2017;377:809–18.
    5. Oldenburg J et al. N Eng J Med 2017;377:809–18 [Supplementary Appendix].

    M-GB-00001029

    Date of preparation: August 2020

    Welcome to Roche Resources

    Roche Resources is intended for UK Healthcare Professionals only. By entering this site you are confirming that you are a UK Healthcare professional.

    I am a healthcare professional I am a member of the public
    • © 2021 Roche Products Limited
    • 19.01.2021
    • Terms and Conditions
    • Privacy Policy
    • Prescribing Information
    • Contact

    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554. ▼Additional monitoring: Medicinal products associated with this symbol are subject to additional monitoring. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. For biological medicines, healthcare professionals should report adverse reactions by brand name and batch number. This is a promotional website intended for HCPs, designed, built and funded by Roche Products Ltd. Commentary and other materials, including external links, posted on this site are not intended to amount to advice on which reliance should be placed. We therefore disclaim all liability and responsibility arising from any reliance placed on such materials by any visitor to our site, or by anyone who may be informed of any of its contents. M-GB-00002434 Date of Preparation January 2021.