Turoctocog alfa for haemophilia A treatmentApril 9, 2019
The US FDA has approved turoctocog alfa pegol, N8-GP (Esperoct) for the treatment of adults and children with haemophilia A.
Turoctocog alfa pegol is indicated for use in adults and children with haemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, Novo Nordisk announced.
The approval is based on the results from the clinical programme conducted in 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure. Turoctocog alfa was shown to provide effective routine prophylaxis in people with severe haemophilia A through a simple, fixed dosing regimen of one injection every 4 days in adults and adolescents or every 3-4 days in children.
Turoctocog alfa is an extended half-life factor VIII molecule for replacement therapy, which provides a 1.6-fold half-life prolongation in adults/adolescents and a 1.9-fold half-life prolongation in children, compared to standard half-life factor VIII products.