Swedish biopharmaceutical company, Swedish Orphan Biovitrum AB, has received a positive recommendation from the Committee for Medicinal Products for Human Use under the European Medicines Agency. This recommendation supports the approval of efanesoctocog alfa, a drug intended for the treatment and prevention of bleeds and to be used as perioperative prophylaxis for those living with haemophilia A.
The recommendation was concluded based on the outcomes from two critical phase 3 studies, XTEND-1 and XTEND-Kids. These studies assessed adults, adolescents, and children for the efficiency and safety of efanesoctocog alfa.
Interestingly, the drug first received approval in the United States in February 2023 by the FDA who also granted Breakthrough Therapy status for the medication in May 2022, followed by Fast Track designation in February 2021, and Orphan Drug designation in 2017.
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