Novo Nordisk has received US Food and Drug Administration (FDA) approval for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of adults and children with haemophilia A.
The decision allows physicians to prescribe the drug for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding.
Clearance is based on the results from the largest preregistration clinical programme conducted in haemophilia A, which included 270 previously treated people with severe the disease, and more than five years of clinical exposure.
In the trial, the drug was shown to provide effective routine prophylaxis by administration of injection every four days in adults and adolescents or twice-weekly in children.
Furthermore, Esperoct was found to be efficacious in treatment and control of bleeding episodes and perioperative management, but due to third-party IP agreements, the Danish drugmaker will not be able to launch the treatment before 2020 in the USA.
“We are excited about the approval of Esperoct in the US, and we consider it an important expansion of the treatment options Novo Nordisk can offer people with haemophilia A”, said Mads Krogsgaard Thomsen, the firm's executive vice president and chief science officer.
“We are confident that Esperoct will provide people with haemophilia A a less burdensome and simple, fixed dosing regimen for prophylaxis and treatment of bleeding episodes, resulting in improved quality of life.”
Esperoct is an extended half-life factor VIII molecule for replacement therapy, which provides a 1.6-fold half-life prolongation in adults and a 1.9-fold half-life prolongation in children.