Health

Sobi Wins EU Approval for Haemophilia A Drug Altuvoct

Jun 19, 2024 1 min read

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The European Commission has granted marketing authorisation for ALTUVOCT™ (efanesoctocog alfa), a high-sustained factor VIII replacement therapy for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. This authorisation follows the recommendation from the European Medicines Agency (EMA) to retain the orphan drug designation, which includes a 10-year market exclusivity period. The decision is based on data from two pivotal phase 3 studies, XTEND-1 in adults and adolescents and XTEND-Kids in children, demonstrating significant improvements in bleed protection and quality of life for patients.

Sobi, the developer of ALTUVOCT, holds commercialisation rights in Europe, North Africa, Russia, and most Middle Eastern markets. The therapy was first approved by the US Food and Drug Administration in February 2023. ALTUVOCT is administered once a week and is expected to generate substantial sales, addressing the significant unmet clinical and social needs of those with haemophilia A. The European Commission's approval positions ALTUVOCT as a promising new option in the landscape of haemophilia A treatments.

#finance #european-union #markets

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