Novo Nordisk announced that the Food and Drug Administration (FDA) has approved Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of patients with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
Esperoct is an extended half-life factor VIII molecule indicated for replacement therapy. Compared to standard half-life factor VIII products, Esperoct provides a 1.6-fold half-life prolongation in adults/adolescents and a 1.9-fold half-life prolongation in children.
Esperoct was evaluated in 5 prospective, multicenter trials (N=270) of previously treated patients with severe hemophilia A and >5 years of clinical exposure with no history of inhibitors. Data included 80,425 exposure days corresponding to 889 patient-years of treatment. Trial results showed that in adults and adolescents, Esperoct, dosed every 4 days, provided effective prophylaxis and was associated with a median annual bleed rate of 1.18. In addition, efficacy was established in the treatment and control of bleeding episodes and perioperative management.
Esperoct was well-tolerated across all studies and age groups; the safety profile was found to be comparable to that seen with other long-acting factor VIII products.
Mads Krogsgaard Thomsen, EVP and CSO of Novo Nordisk, stated, “We are confident that Esperoct will provide people with hemophilia A a less burdensome and simple, fixed dosing regimen for prophylaxis and treatment of bleeding episodes, resulting in improved quality of life.”
Esperoct is not expected to be available in the US until 2020.
For more information visit NovoNordisk.com.