Esperoct approved in the EU for hemophilia A

21 June 2019

Danish diabetes care giant Novo Nordisk (NOV: N) announced late yesterday d that the European Commission has granted marketing authorization for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of adolescents (≥12 years of age) and adults with hemophilia A. The authorization covers all 28 European Union member states.

Esperoct is indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with hemophilia A (congenital factor VIII deficiency). The efficacy and safety evaluation was based on the results from the largest pre-registration clinical program conducted in hemophilia A, with inclusion of 270 previously treated people (PTPs) with severe hemophilia A and more than five years of clinical exposure.

The marketing authorization follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), provided on April 26, 2019.

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