Novo Nordisk has announced that its Esperoct (turoctocog alfa pegol, N8-GP) has been granted european marketing authorisation for adolescents (≥12 years of age) and adults with haemophilia A.
The European Commission granted the authorisation for the indication of prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with haemophilia A.
The decision also follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 26 April 2019.
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 with severe haemophilia A, and more than five years of clinical exposure.
The company is “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.
He continued, “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 the drug in the first European countries during the second half of 2019.
Haemophilia A is the most common type of haemophilia, with a prevalence of between 1:5,000 and 1:10,000 males in the UK.