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Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of hemophilia A

Plainsboro, NJ, Feb. 27, 2018 – Novo Nordisk today announced the submission of a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for N8-GP, an extended half-life factor VIII for treatment of people with hemophilia A.

The submission is based on results from the pathfinder clinical trial program. The pathfinder program included 270 previously treated people with hemophilia A and investigated efficacy and safety of N8-GP in adults and children as well as people undergoing surgery.

Across the pathfinder clinical trial program, the most common adverse reactions were rash, erythema, pruritus and injection site reactions.

“We are excited to file the regulatory application for long-acting N8-GP in the US and EU,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Based on the results from the global pathfinder clinical trial program, we believe N8-GP has the potential to reduce the burden of treatment by decreasing the number of intravenous infusions for people with hemophilia A compared with standard half-life factor VIII products.”

About N8-GP

N8-GP is a glycopegylated B-domain truncated recombinant factor  designed for prolonged half-life. The site specific glycopegylation is within the truncated B-domain. When activated by thrombin at the site of injury, the B-domain containing the PEG is cleaved off, generating Factor VIII which is similar in structure to native Factor VIIIa.

About the pathfinder phase 3a clinical trial program

The pathfinder program included 202 previously treated adolescents/adults and 68 previously treated with hemophilia A and investigated safety and efficacy of N8-GP over 889 patient years of treatment, including treatment of bleeds, prophylaxis and surgery.

Pathfinder 2 was a global trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in people with hemophilia A, who are 12 years or older. 175 people were treated with a prophylactic regimen of 50 IU/kg every fourth day and 12 people received on-demand treatment, when bleedings occurred. During 2 extension phases, some patients were treated with 75 IU/kg every 7 days.

Pathfinder 3 was a surgery trial which was performed as an open-label, multi-national trial evaluating the efficacy and safety of N8-GP when administered for perioperative management in previously treated patients with severe hemophilia A who were 12 years or older. The trial included 33 people who underwent 45 major surgeries.

Pathfinder 5 was a pediatric trial which was performed as a global trial evaluating safety and efficacy for N8-GP, when administered for prophylaxis in previously treated children with hemophilia A, who were between 0 to 11 years old. In the trial, 34 children 0-5 years of age and 34 children 6-11 years of age received prophylactic treatment and treatment of bleeding episodes. All 68 children were treated with a regimen of 60 IU/kg (50-75 IU/kg) twice weekly for 26 weeks in the main phase, and 63 followed through an extension for an average of 3.4 years.

About Novo Nordisk

Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

 

© 2018 Novo Nordisk     All rights reserved.    USA18BIO00761     February 2018

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