The European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents and adults with haemophilia A.
The authorisation covers all 28 European Union member states.
Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct is indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with haemophilia A (congenital factor VIII deficiency). The efficacy and safety evaluation was based on the results from the largest pre-registration clinical programme conducted in haemophilia A, with inclusion of 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure. The marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 26 April 2019.
Expected launch during the second half of 2019
“We are excited about the approval of Esperoct in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia A,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are confident that Esperoct will provide people with haemophilia A a simple and less burdensome, predictable dosing regimen for prophylaxis as well as treatment of bleeding episodes, resulting in improved quality of life.”
Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.
Photo of Mads Krogsgaard Thomsen: Novo Nordisk