FX.co ★ Swedish Orphan Biovitrum: EU Grants Marketing Authorisation For ALTUVOCT To Treat Haemophilia A

Swedish Orphan Biovitrum AB, commonly known as Sobi (BIOVF.PK), announced on Wednesday that the European Commission has granted Marketing Authorisation for ALTUVOCT (efanesoctocog alfa). This therapy is designed to treat and prevent bleeding episodes, as well as provide perioperative prophylaxis in individuals with haemophilia A.

Haemophilia A is a rare, lifelong genetic disorder where the body either does not produce enough factor VIII, or the factor VIII produced is dysfunctional. Factor VIII is a crucial protein required for blood clotting.

ALTUVOCT serves as a high-sustained factor VIII replacement therapy suitable for patients of all ages and with varying severities of the disease.

The European Commission's decision followed the European Medicines Agency's (EMA) recommendation to uphold ALTUVOCT's orphan drug designation, which includes a 10-year period of market exclusivity. The EMA's endorsement highlighted that the once-weekly prophylaxis provided by ALTUVOCT significantly reduced the annual bleeding rate compared to other factor VIII therapies, presenting a clinically relevant advantage.

The Marketing Authorisation was granted based on results from pivotal phase 3 trials: XTEND-1, which involved adults and adolescents, and XTEND-Kids, which focused on children. These studies assessed the efficacy and safety of ALTUVOCT in individuals with severe haemophilia A.

ALTUVOCT initially received approval in the United States in February 2023 from the U.S. Food and Drug Administration (FDA). The FDA had also 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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