PharmaWatch: FDA Approves Esperoct as Prophylactic Treatment for Hemophilia Say Novo Nordisk


“Hemophilia A News Today” reports Children and adults with hemophilia A in the United States may soon be treated with N8-GP (turoctocog alfa pegol), an engineered formulation of clotting factor VIII developed by Novo Nordisk. The therapy will be available under the brand name Esperoct.

The U.S. Food and Drug Administration (FDA) approved N8-GP, or Esperoct, as a prophylactic (preventive) therapy to reduce frequency of bleeds and for on-demand use to control bleeding episodes in patients with inherited factor VIII deficiency.

Esperoct will not arrive on the U.S. market before 2020, due to third-party intellectual propriety agreements.

“We are excited about the approval of Esperoct in the U.S., and we consider it an important expansion of the treatment options Novo Nordisk can offer people with hemophilia A,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, a Danish company.

“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,” he said.

Esperoct is an engineered factor VIII molecule designed to have enhanced stability and provide better blood clotting ability for hemophilia A patients.