Shots:

• The approval is based on results from pre-registration clinical programme assessing Esperoct in 270 patients with severe hemophilia A with 5+years of clinical exposure. The authorization covers all 28 European Union member states
• The marketing authorization follows EMA’s CHMP positive opinion granted on Apr 26- 2019 with its expected launch in European countries in H2’19
• Esperoct is an extended half-life factor VIII molecule providing 1.6fold half-life prolongation- indicated for the prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents (≥12yrs.) and adults with hemophilia A

Ref: Novo Nordisk | Image: IVSA