Sobi ® today announced the European Commission has granted Marketing Authorization for ALTUVOCTTM (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. ALTUVOCT is a high-sustained factor VIII replacement therapy for all ages and any disease severity. Children, adolescents, and adults can experience non-hemophilia factor VIII activity levels (above 40%) for a significant part of the week with once-weekly prophylaxis, reaching trough levels of 15% in adults and adolescents before the next dose.
This results in significantly improved protection from bleeds compared to prior factor VIII prophylaxis. The European Commission also endorsed the European Medicines Agency (EMA) recommendation supporting ALTUVOCT's retention of orphan drug designation, granting a 10-year market exclusivity period. The EMA recommendation noted that even considering existing treatments, once-weekly ALTUVOCT prophylaxis demonstrated a significantly lowered annual bleeding rate compared to other factor VIII products, and this constitutes a clinically relevant advantage.
“Despite advancements, hemophilia still limits the possibilities of patients’ lives and this means there is still a need for treatments that offer elevated protection. ALTUVOCT’s high-sustained factor VIII activity and once-weekly dosing schedule have the potential to significantly improve quality of life for people with hemophilia A. The trials demonstrated substantial improv.
