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European approval for Novo's Esperoct in haemophilia A

Published on 21/06/19 at 10:22am

The European Commission has awarded approval to Novo Nordisk’s extended half-life factor VIII therapy Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of haemophilia A in adolescent and adult patients, the drugmaker has revealed.

Specifically, the approval covers “the prophylaxis and on-demand treatment of bleeding as well as for surgical procedures”. The decision from the EC comes after a positive opinion from the Committee for Medicinal Products for Human Use in April, and was based on data derived from the largest pre-registration clinical programme ever undertaken in this disease area, demonstrating the therapy’s efficacy in 270 previously untreated severe haemophilia A patients over five years.

“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."

Esperoct is expected to launch in Europe in the second half of the year.

Matt Fellows

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