March 1, 2019

New EHL factor VIII approved in US

The US Food and Drug Administration has approved Novo Nordisk’s extended half-life factor VIII for prophylaxis and treatment in children and adults with severe haemophilia A.

Turoctocog alfa pegol (Esperoct) is a pegylated version of Novo’s recombinant factor VIII NovoEight. The company says that, compared with standard factor VIII, half-life is increased by a factor of 1.6 in adults and adolescents and 1.9 in children. In a clinical trial involving 270 previously-treated patients, turoctocog alfa pegol was administered in a fixed dose frequency of once every 4 days in adults and once every 3 – 4 days in children. The mean annualised bleeding rate was 1.18.