Novo Nordisk's Esperoct gains European approval for adolescents, adults with haemophilia A

Novo Nordisk on Thursday announced that the European Commission granted marketing authorisation to Esperoct (turoctocog alfa pegol) for use in adolescents aged 12 years and older and adults with haemophilia A. Chief science officer Mads Krogsgaard Thomsen remarked "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."

The approval was backed by safety and efficacy data from a clinical trial programme involving 270 previously treated patients with severe haemophilia A and more than 5 years of clinical exposure. Study results revealed that Esperoct was associated with an annual bleeding rate of 1.18 at a dose of 50 IU/kg every 4 days in adults and adolescents, while the treatment effectively treated and controlled bleeding episodes. The drugmaker added that the therapy "was found to be efficacious in treatment and control of bleeding episodes and perioperative management."

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion backing approval of Esperoct for this indication in April. Novo Nordisk said that it plans to launch the treatment in certain European countries in the second half of the year.

Meanwhile, Esperoct was cleared by the FDA for the treatment of haemophilia A in children and adults in February.

To read more Top Story articles, click here.