Novo Nordisk released new Phase 3 interim data from its guardian™2 trial for NovoEight® (turoctocog alfa pegol), the company’s third-generation, long-acting recombinant factor VIII (rFVIII) product for the prevention and treatment of bleeding in people with hemophilia A.
The data, presented during the World Federation of Hemophilia (WFH) 2014 World Congress, May 11-15, 2014, in Melbourne, Australia, showed that NovoEight was effective in treating and preventing bleeds in previously treated patients with hemophilia A, while also preventing the development of inhibitor antibodies. The overall estimated annual bleeding rate (ABR) achieved during a prophylactic regimen with NovoEight was 1.7 (median 3.1), ranging from 1.4 (children aged 0-5) to 1.9 for adults. The preventive regimen with NovoEight led to an overall decrease in ABR.
“As a physician treating hemophilia A, having another FVIII product available is good news and can lead to improved treatment outcomes and quality of life for our patients. Reducing the number of bleeding episodes is a key consideration as they are very painful and frightening for patients and caregivers, and can lead to severe long-term joint damage or arthropathy,” said guardian2 investigator, Margareth Ozelo, MD, PhD, Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil.
Source: dddmag.com, May 12, 2014
