Summary

 
ELOCTA®, combines the benefits of rFVIII and Fc fusion technology to extend the half-life of FVIII, to allow for personalisation of treatment and to offer the potential for intense protection, without additional burden1

 

Giving them long-term confidence1–3
  • Enhance treatment individualisation possibilities1,2,19
  • PK profile shows higher plasma levels for longer with factor with Fc half-life extension vs standard half-life rFVIII2
  • Indicated across all ages and different clinical settings1
  • Well-established efficacy and safety profile in clinical trials1,2,4,5
  • >5 years’ real-world experience1,3
Protecting their joint health2,4-9
  • Zero median joint AsBRs2,4-6
  • 99.6% of baseline target joints resolved7
  • Continuous improvements in mHJHS from baseline8,9
Improving their quality of life2,4,10-12
  • Significant improvement in QoL after switching from prophylaxis with standard half-life rFVIII10,11
  • Up to 50% reduction in annual injections vs standard half-life rFVIII12

ELOCTA®: proven protection in all age groups and different clinical settings1,2,4,5,9,11,13-18

AsBRs, annualised spontaneous bleed rates; Fc, fragment crystallisable; mHJHS, modified haemophilia joint health score; PK, pharmacokinetics; QoL, quality of life; rFVIII, recombinant Factor VIII.

References

  1. ELOCTA Summary of Product Characteristics. 2019.

  2. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

  3. FDA. Eloctate® (rFVIIIFc) Prescribing Information. https://www.fda.gov/media/88746/download. Last accessed, May 2019.

  4. Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, et al. Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A. J Thromb Haemost. 2015 Jun;13(6):967–77.

  5. Nolan B, Mahlangu J, Young G, Konkle B, Pasi KJ, Oldenburg J, et al. ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A. Poster presented at the 60th American Society of Hematology Annual Meeting & Exposition, December 1–4, 2018, San Diego, CA, USA. Poster 1192.

  6. Nolan B, Mahlangu J, Perry D, Young G, Liesner R, Konkle B, et al. Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A. Haemophilia. 2016 Jan;22(1):72-80.

  7. Pasi KJ, Pabinger I, Wang M, Kerlin B, Kulkarni R, Nolan B, et al. Long-term Impact of rFVIIIFc prophylaxis in Paediatric, Adolescent, and Adult Subjects with Target Joints and Severe Haemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB212.

  8. Oldenburg J, Kulkarni R, Srivastava A, Mahlangu JN, Tsao E, Winding B. Longitudinal Modified Hemophilia Joint Health Scores (mHJHS) in Children, Adolescents, and Adults with Severe Hemophilia A with Long-term rFVIIIFc Prophylaxis. Abstract presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB946.

  9. Oldenburg J, Kulkarni R, Srivastava A, Mahlangu JN, Blanchette VS, Tsao E. Improved joint health in subjects with severe haemophilia A treated prophylactically with recombinant factor VIII Fc fusion protein. Haemophilia. 2018 Jan;24(1):77–84.

  10. Wyrwich KW, Krishnan S, Auguste P, Poon JL, von Maltzahn R, Yu R, et al. Changes in health-related quality of life with treatment of longer-acting clotting factors: results in the A-LONG and B-LONG clinical studies. Haemophilia 2016; Nov;22(6):866-72.

  11. Su J, Tsao E, Feng J, Myren KJ, Glazebrook D. Long-Term Quality-of-Life Outcomes with rFVIIIFc Prophylaxis in Adult Subjects with Severe Hemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB1783.

  12. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.

  13. Konkle B, Young G, Liesner R, Mahlangu J, Brown SA, Nolan B, et al. Long-term efficacy and safety of prophylactic treatment with recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with severe haemophilia A: final longitudinal analysis of A-LONG/Kids A-LONG and ASPIRE. Poster presented at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. Poster P039.

  14. Königs C, Liesner R, Ozelo MC, Shapiro AD, Brown SA, Innes A, et al. Incidence of inhibitors in previously untreated patients with severe haemophilia A treated with rFVIIIFc: The PUPs A-LONG study. Oral presentation at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. Oral Presentation OR14.

  15. Quon DV, Klamroth R, Kulkarni R, Shapiro AD, Baker RI, Castaman G, et al. Low bleeding rates with increase or maintenance of physical activity in patients treated with recombinant factor VIII Fc fusion protein (rFVIIIFc) in the A-LONG and Kids A-LONG studies. Haemophilia. 2017 Jan;23(1):e39–e42.

  16. Oldenburg J, Pasi J, Pabinger I, Nolan B, Kulkarni R, Blanchette V, et al. Improvements in joint health during long-term use of recombinant factor VIII Fc fusion protein prophylaxis in subjects with haemophilia A. Poster presented at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. P158.

  17. Mahlangu JN, Ragni M, Gupta N, Rangarajan S, Klamroth R, Oldenburg J, et al. Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A. Thromb Haemost. 2016 Jul 4;116(1):1-8.

  18. Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.

  19. Berntorp E, Negrier C, Gozzi P, Blaas PM and Lethagen S. Dosing regimens, FVIII levels and estimate. Haemophilia 2016;1-8.

Summary

 
ELOCTA®, combines the benefits of rFVIII and Fc fusion technology to extend the half-life of FVIII, to allow for personalisation of treatment and to offer the potential for intense protection, without additional burden1

 

Giving them long-term confidence1–3
  • Enhance treatment individualisation possibilities1,2,19
  • PK profile shows higher plasma levels for longer with factor with Fc half-life extension vs standard half-life rFVIII2
  • Indicated across all ages and different clinical settings1
  • Well-established efficacy and safety profile in clinical trials1,2,4,5
  • >5 years’ real-world experience1,3
Protecting their joint health2,4-9
  • Zero median joint AsBRs2,4-6
  • 99.6% of baseline target joints resolved7
  • Continuous improvements in mHJHS from baseline8,9
Improving their quality of life2,4,10-12
  • Significant improvement in QoL after switching from prophylaxis with standard half-life rFVIII10,11
  • Up to 50% reduction in annual injections vs standard half-life rFVIII12

ELOCTA®: proven protection in all age groups and different clinical settings1,2,4,5,9,11,13-18

AsBRs, annualised spontaneous bleed rates; Fc, fragment crystallisable; mHJHS, modified haemophilia joint health score; PK, pharmacokinetics; QoL, quality of life; rFVIII, recombinant Factor VIII.

References

  1. ELOCTA Summary of Product Characteristics. 2019.

  2. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

  3. FDA. Eloctate® (rFVIIIFc) Prescribing Information. https://www.fda.gov/media/88746/download. Last accessed, May 2019.

  4. Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, et al. Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A. J Thromb Haemost. 2015 Jun;13(6):967–77.

  5. Nolan B, Mahlangu J, Young G, Konkle B, Pasi KJ, Oldenburg J, et al. ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A. Poster presented at the 60th American Society of Hematology Annual Meeting & Exposition, December 1–4, 2018, San Diego, CA, USA. Poster 1192.

  6. Nolan B, Mahlangu J, Perry D, Young G, Liesner R, Konkle B, et al. Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A. Haemophilia. 2016 Jan;22(1):72-80.

  7. Pasi KJ, Pabinger I, Wang M, Kerlin B, Kulkarni R, Nolan B, et al. Long-term Impact of rFVIIIFc prophylaxis in Paediatric, Adolescent, and Adult Subjects with Target Joints and Severe Haemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB212.

  8. Oldenburg J, Kulkarni R, Srivastava A, Mahlangu JN, Tsao E, Winding B. Longitudinal Modified Hemophilia Joint Health Scores (mHJHS) in Children, Adolescents, and Adults with Severe Hemophilia A with Long-term rFVIIIFc Prophylaxis. Abstract presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB946.

  9. Oldenburg J, Kulkarni R, Srivastava A, Mahlangu JN, Blanchette VS, Tsao E. Improved joint health in subjects with severe haemophilia A treated prophylactically with recombinant factor VIII Fc fusion protein. Haemophilia. 2018 Jan;24(1):77–84.

  10. Wyrwich KW, Krishnan S, Auguste P, Poon JL, von Maltzahn R, Yu R, et al. Changes in health-related quality of life with treatment of longer-acting clotting factors: results in the A-LONG and B-LONG clinical studies. Haemophilia 2016; Nov;22(6):866-72.

  11. Su J, Tsao E, Feng J, Myren KJ, Glazebrook D. Long-Term Quality-of-Life Outcomes with rFVIIIFc Prophylaxis in Adult Subjects with Severe Hemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB1783.

  12. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.

  13. Konkle B, Young G, Liesner R, Mahlangu J, Brown SA, Nolan B, et al. Long-term efficacy and safety of prophylactic treatment with recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with severe haemophilia A: final longitudinal analysis of A-LONG/Kids A-LONG and ASPIRE. Poster presented at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. Poster P039.

  14. Königs C, Liesner R, Ozelo MC, Shapiro AD, Brown SA, Innes A, et al. Incidence of inhibitors in previously untreated patients with severe haemophilia A treated with rFVIIIFc: The PUPs A-LONG study. Oral presentation at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. Oral Presentation OR14.

  15. Quon DV, Klamroth R, Kulkarni R, Shapiro AD, Baker RI, Castaman G, et al. Low bleeding rates with increase or maintenance of physical activity in patients treated with recombinant factor VIII Fc fusion protein (rFVIIIFc) in the A-LONG and Kids A-LONG studies. Haemophilia. 2017 Jan;23(1):e39–e42.

  16. Oldenburg J, Pasi J, Pabinger I, Nolan B, Kulkarni R, Blanchette V, et al. Improvements in joint health during long-term use of recombinant factor VIII Fc fusion protein prophylaxis in subjects with haemophilia A. Poster presented at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 6–8 February 2019, Prague, Czech Republic. P158.

  17. Mahlangu JN, Ragni M, Gupta N, Rangarajan S, Klamroth R, Oldenburg J, et al. Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A. Thromb Haemost. 2016 Jul 4;116(1):1-8.

  18. Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.

  19. Berntorp E, Negrier C, Gozzi P, Blaas PM and Lethagen S. Dosing regimens, FVIII levels and estimate. Haemophilia 2016;1-8.