Novo Nordisk Receives FDA Approval for Hemophilia A Treatment

Industry NewsThe following is an excerpt from a press release. Read the press release in its entirety here.

Denmark-based Novo Nordisk received approval from the U.S. Food and Drug Administration for a new treatment for hemophilia A. However, the newly approved medication will not be available in the United States until 2020.
Novo Nordisk said the FDA approved its Biologics License Application for Esperoct (turoctocog alfa pegol) formerly known as N8-GP, for the treatment of children and adults with hemophilia A. Esperoct, is an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A, was approved for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
“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,” Thomsen said in a brief statement.
Despite that confidence in the benefits of Esperoct, Novo Nordisk said the treatment will not be available in the United States for at least another year. The company laid the blame at the feet of third-party intellectual property agreements.
The Novo Nordisk hemophilia treatment was approved based on clinical trial results that included 270 previously treated people with severe hemophilia A and more than five years of clinical exposure. During the clinical trials, Esperoct was shown to provide “effective routine prophylaxis” in people with severe hemophilia A. The medication was delivered to the patients through a fixed dosing regimen of one injection every four days for adolescents or adults, or every three to four days in children. During the trial, Esperoct was shown to provide effective prophylaxis. Additionally, patients were able to maintain a low median annualized bleeding rate of 1.18 when dosing was maintained.
Read the press release in its entirety here.