Sobi® has announced a significant milestone in haemophilia care with the European Commission granting Marketing Authorisation for ALTUVOCT (efanesoctocog alfa). This cutting-edge treatment offers improved protection from bleeds and perioperative prophylaxis for individuals with haemophilia A.
The European Commission’s endorsement of ALTUVOCT’s retention of orphan drug designation underscores the clinical relevance of this therapy. ALTUVOCT provides a once-weekly dosing schedule, maintaining non-haemophilia factor VIII activity levels for a significant part of the week, resulting in enhanced protection from bleeds compared to previous treatments.
Professor Robert Klamroth, MD, PhD, highlighted the potential of ALTUVOCT to significantly enhance the quality of life for people with haemophilia A. Clinical trials demonstrated substantial improvements in bleed prevention, joint health, and overall quality of life.
The Marketing Authorisation is based on the results from pivotal phase 3 studies, demonstrating the efficacy and safety of ALTUVOCT in individuals with severe haemophilia A. Once-weekly prophylaxis with ALTUVOCT provided significant bleed protection and improved quality of life outcomes across all age groups.
The introduction of ALTUVOCT marks a major advancement in haemophilia care, offering the potential to significantly improve treatment outcomes and quality of life. With its once-weekly dosing schedule and sustained factor VIII activity levels, ALTUVOCT represents a paradigm shift towards normal haemostasis.
Haemophilia A is a rare genetic condition that affects the body’s ability to produce functional factor VIII, necessary for blood clotting. ALTUVOCT’s approval in the US in February 2023 and now in Europe represents a crucial step forward in addressing unmet clinical needs for individuals living with haemophilia A.
ALTUVOCT’s innovative approach, coupled with its high-sustained factor VIII activity and once-weekly dosing schedule, has the potential to transform the lives of individuals with haemophilia A. The collaboration between Sobi and Sanofi aims to provide accessible and innovative treatment options for rare and debilitating diseases, offering hope and improved outcomes for patients worldwide.
