Challenges persist in haemophilia A
Despite prophylaxis, bleeds persist in people with haemophilia A7–9
Patients continue to experience both clinically evident and subclinical bleeding events,7–9 where even a single event can lead to irreversible joint damage.10
How can we drive better patient outcomes?
Targeting FVIII levels in the non-haemophilia range (>40 IU/dL)2 may provide patients freedom from bleeds and protection from joint damage.2,11–13
ALTUVOCT is the first ultra-long half-life FVIII therapy14,15
ALTUVOCT leverages innovative bioengineering to extend half-life4
As the first factor replacement to decouple from vWF, ALTUVOCT provides the opportunity to overcome the vWF-imposed half-life ceiling.4
This extends half-life for 4x longer than SHL FVIII (octocog alfa) and 3x longer than EHL FVIII (rurioctocog alfa).16
ALTUVOCT dosing across different clinical settings
ALTUVOCT offers once-weekly treatment for prophylaxis, with the same fixed dose across surgery and on-demand treatment.17,18
Across the XTEND trials, once-weekly, fixed-dose ALTUVOCT delivered:
Sustained FVIII levels >40 IU/dL for up to 4 days in adults and adolescents,4 and ~3 days in children5
Effective bleed protection, with zero bleeds reported in the majority of patients4,5
In XTEND-1, 65% of patients on ALTUVOCT prophylaxis reported zero bleeds (n=86/133)*4
In XTEND-Kids, 64% of patients reported zero bleeds (n=47/73)†5
Effective joint protection, with improved joint health scores vs baseline4,5
In XTEND-1 and XTEND-Kids, mean HJHS decreased‡ from baseline to Week 52 in patients on ALTUVOCT prophylaxis
XTEND-1 (n=133) mean change: −1.54 (95% CI: −2.70 to −0.37; P=0.01)4
XTEND-Kids (N=74) mean change (SD): −0.6±6.0 points5
A generally well-tolerated safety profile, with no inhibitors detected across trials4,5,19–21
EXPLORE the EFFICACY AND SAFTEY PROFILE altuvoct in adults
EXPLORE the EFFICACY AND SAFTEY PROFILE altuvoct in CHILDREN
*Primary endpoint in XTEND-1 (model-based mean overall ABR [95% CI] in Group A [n=133] at Week 52: 0.71 (0.52–0.97).4 † Bleeding episodes are reported for the sensitivity analysis set (n=73), an ad hoc analysis which included 73 patients treated according to protocol. One patient was excluded from the sensitivity analysis due to the return of a positive baseline FVIII inhibitor result after the patient had initiated treatment. The patient was subsequently withdrawn from the study after receiving three doses. The primary endpoint in XTEND-Kids was occurrence of inhibitor development (95% CI; N=74): 0 (0–5).5 ‡Scores range from 0 to 124, with lower scores indicating better joint health.4,5
ABR, annualised bleeding rate; CI, confidence interval; EHL, extended half-life; FVIII, factor VIII; HJHS, Haemophilia Joint Health Score; SD, standard deviation; SHL, standard half-life; vWF, von Willebrand factor.
1. Srivastava A, et al. Haemophilia. 2020;26 Suppl. 1–158. 2. Malec L, Matino D. Haemophilia. 2023;29:1419–1429. 3. Holme PA, et al. Haemophilia. 2024;30(5):1109–1114. 4. von Drygalski A, et al. N Engl J Med. 2023;388(4):310–318. 5. Malec L, et al. N Engl J Med. 2024;391:235–246. 6. Maneikis K, et al. Res Pract Thromb Haemost. 2025;9(7):103200. 7. Chowdary P, et al. TH Open. 2025;9:a26219749. 8. Levy-Mendelovich S, et al. J Clin Med. 2021;10:4303–4312. 9. Di Minno D, et al. Haemophilia. 2013;19(3):167–173. 10. Mancuso ME, et al. Haemophilia. 2023;29:619–628. 11. Chowdary P, et al. J Thromb Haemost. 2020;120:728–736. 12. Madan B, et al. J Thromb Haemost. 2024;22(7):1880–1893. 13. Tiede A, et al. Haematologica. 2021;106:1902–1909. 14. Hermans C, Pierce GF. Journal of Thrombosis and Haemostasis. 2024;22(7):1844–1846. 15. Burke T, et al. Expert Rev Hematol. 2026;19(1):55–61. 16. Lissitchkov T, et al. Res Pract Thromb Haemost. 2023;7(4):100176. 17. ALTUVOCT UK Summary of Product Characteristics. 18. ALTUVOCT EU Summary of Product Characteristics. 19. Klamroth R, et al. Blood. 2024;717–718. 20. Malec L, et al. Blood. 2024;5495–5496. 21. Susen S, et al. EAHAD 2026. Dublin, Ireland. Oral presentation.
In the UK, ALTUVOCT (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients 2 years and above with severe or moderate haemophilia A (≤5% endogenous plasma factor VIII activity). There are limited data in paediatric patients <2 years of age.17
In Ireland, ALTUVOCT (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ALTUVOCT can be used for all age groups.18
| ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found, for United Kingdom: via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. For Ireland: via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events should also be reported to Swedish Orphan Biovitrum Ltd by email at [email protected] or by calling +44 (0) 800 111 4754. |