Swedish Orphan Biovitrum AB or Sobi (BIOVF.PK) announced Wednesday that the European Commission has granted Marketing Authorisation for ALTUVOCT (efanesoctocog alfa), to treat and prevent bleeds and perioperative prophylaxis in haemophilia A.
Haemophilia A is a rare, lifelong genetic condition in which the body does not produce enough, or makes dysfunctional, factor VIII - a protein that is essential for blood clotting.
ALTUVOCT is a high-sustained factor VIII replacement therapy for all ages and any disease severity.
The European Commission also endorsed the European Medicines Agency or EMA recommendation supporting ALTUVOCT's retention of orphan drug designation, granting a 10-year market exclusivity period.
The EMA recommendation noted that once-weekly ALTUVOCT prophylaxis, even considering existing treatments, demonstrated a significantly lowered annual bleeding rate compared to other factor VIII products, and this constitutes a clinically relevant advantage.
The granting of Marketing Authorisation is based on the results from the pivotal phase 3 studies: XTEND-1 in adults and adolescents and XTEND-Kids in children. These trials evaluated the efficacy and safety of ALTUVOCT in people with severe haemophilia A.
ALTUVOCT was first approved in the US in February 2023 by the US Food and Drug Administration, which previously granted efanesoctocog alfa Breakthrough Therapy designation in May 2022, Fast Track designation in February 2021, and Orphan Drug designation in 2017.
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