Posted from: Thursday, March 07, 2019 - 10:24 AM - Present

Esperoct Approved to Treat Hemophilia A

February 19, 2019 – The U.S. FDA has approved Esperoct® (turoctocog alfa pegol, N8-GP), manufactured by Novo Nordisk, to treat adults and children who have hemophilia A. The drug is indicated to provide routine prophylaxis to reduce the frequency of bleeding episodes, as well as on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

Hemophilia A affects approximately 500 babies born each year. The rare bleeding disorder is caused by an inherited mutation on the F8 gene. This mutation reduces the body’s ability to produce Factor VIII protein, which is needed for proper blood clotting. Patients are typically diagnosed at an early age, and require life-long treatment to manage the disease. 

In clinical studies, Esperoct was found effective in reducing and controlling bleeding episodes, as well as managing bleeding during surgery (perioperative management). The drug was well-tolerated and has a safety profile similar to comparable products. Recommended dosing is once every four days for adults, and once every three to four days for children. The total dose administered is based on weight.

Due to third-party IP agreements, Esperoct will not launch until 2020.

Last Updated Wednesday, July 17, 2019 - 09:45 AM.