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FDA Approves Long-Acting Factor FVIII Product for Hemophilia A

February 22, 2019
FDA Approves Long-Acting Factor FVIII Product for Hemophilia A

The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for N8-GP Turoctocog alfa pegol (Esperoct), Novo Nordisk’s long-acting recombinant factor VIII product for the prevention and treatment of bleeding in individuals with hemophilia A. The new therapy is specifically indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment, and control of bleeding episodes and perioperative management of bleeding.

The approval was based on a series of successful clinical trials designed to evaluate the safety and efficacy of Esperoct in 270 previously-treated patients with severe hemophilia A. According to a recent press release, “due to third-party IP agreements,” Novo Nordisk will not launch the product in the U.S. before 2020.  

“We are excited about the approval of Esperoct in the US, and we consider it an important expansion of the treatment options Novo Nordisk can offer people with hemophilia A,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a statement. “We are confident that Esperoct will provide people with hemophilia A a less burdensome and simple, fixed dosing regimen for prophylaxis and treatment of bleeding episodes, resulting in improved quality of life.”

Source: Specialty Pharmacy Times, February 19, 2019