Novo Nordisk has announced that its hemophilia A product Eperoct (turoctocog alfa pegol, N8-GP) was approved in the European Union.
Novo Nordisk has announced the European Commission has approved Esperoct (turoctocog alfa pegol, N8-GP) for the prevention and on-demand treatment of patients suffering from hemophilia A. The drug is indicated for the treatment of adolescents and adults.
The approval was based on the clinical trial, including 270 individuals who had severe hemophilia A and were under treatment for five years. Esperoct showed an annual bleeding rate of 1.18 when dosed at 50 IU/kg every four days. There were no significant safety concerns observed during the clinical trials.