The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.
Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.
The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.
The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.
Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).
Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).