20 June 2019 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (≥12 years of age) and adults with haemophilia A. 

The authorisation covers all 28 European Union member states.

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 CHMP under the EMA, provided 26 April 2019.

Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.

Read Novo Nordisk press release