Bagsværd, Denmark, 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.
Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct 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). 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 Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 26 April 2019.
"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."
Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.
About Esperoct
Esperoct (turoctocog alfa pegol, N8-GP) is an extended half-life factor VIII molecule for replacement therapy in people with haemophilia A, which provides a 1.6-fold half-life prolongation in adults/adolescents compared to standard half-life factor VIII products.
Esperoct was shown to provide effective routine prophylaxis in people with severe haemophilia A through a simple, predictable dosing regimen of one injection every 4 days in adults and adolescents. Esperoct provided effective prophylaxis with an annual bleeding rate of 1.18 when dosed at 50 IU/kg every 4 days in adults and adolescents. Furthermore, Esperoct was found to be efficacious in treatment and control of bleeding episodes and perioperative management. Across the clinical trials and age groups, Esperoct was well tolerated and no safety concerns were identified. The overall safety profile of Esperoct is similar to what has been reported for other long-action FVIII products.
Further information
| Media: | ||
| Mette Kruse Danielsen | +45 4442 3883 | mkd@novonordisk.com (mailto:mkd@novonordisk.com) |
| Ken Inchausti (US) | +1 609 240 9429 | kiau@novonordisk.com (mailto:mailtokiau@novonordisk.com) |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com (mailto:phak@novonordisk.com) |
| Valdemar Borum Svarrer | +45 3079 0301 | jvls@novonordisk.com (mailto:jvls@novonordisk.com) |
| Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com (mailto:arnd@novonordisk.com) |
| Kristoffer Due Berg (US) | +1 609 235 2989 | krdb@novonordisk.com (mailto:krdb@novonordisk.com) |
Attachment
- CA190620_Esperoct_EU_Approval (https://ml-eu.globenewswire.com/Resource/Download/9f40800c-bab2-43fe-8a35-22c9b2b7ddcf)
