19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct for the treatment of adults and children with haemophilia A.

Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct 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, on-demand treatment and control of bleeding episodes and peri-operative management of bleeding.

The approval of Esperoct is based on the results from the largest pre-registration clinical programme conducted in haemophilia A, which included 270 previously treated people with severe haemophilia A and more than 5 years of clinical exposure.

Read Novo Nordisk press release