Esperoct (antihemophilic factor [recombinant], glycopegylated-exei] launched in U.S. for treatment of adults and children with haemophilia A

FDA approval is based on data from 5 multinational trials (n=270) which showed that Esperoct provided effective routine prophylaxis through a fixed dosing regimen of one injection every 4 days in adults and adolescents or every 3-4 days (twice-weekly) in children.

SPS commentary:

Esperoct is a recombinant extended half-life factor VIII replacement therapy used to prevent or reduce the number of bleeding episodes, to treat and control bleeding, and to manage bleeding during surgery in people with haemophilia A. It was approved in the EU in June 2019.

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