Novo Nordisk receives EU marketing authorisation for Esperoct.
NORDIC BUSINESS REPORT-June 21, 2019-Novo Nordisk receives EU marketing authorisation for Esperoct
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Global pharmaceutical company Novo Nordisk A/S (CPH:NOVOB) said on Thursday that the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (aged 12 years or over) and adults with haemophilia A. This authorisation covers all 28 EU member states.
Esperoct, the brand name for turoctocog alfa pegol, N8-GP, is indicated for prophylaxis and on-demand treatment of bleeding, as well as for surgical procedures in adolescents and adults with haemophilia A (congenital factor VIII deficiency).
According to the company, 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 five years of clinical exposure. This marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 26 April 2019.
Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.
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|Publication:||Nordic Business Report|
|Date:||Jun 21, 2019|
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