On March 12th, Sanofi-Aventis Korea, the local offshoot of the global healthcare company Sanofi, has launched Alprolix, a recombinant FIX Fc fusion protein (rFIXFc; eftrenonacog alfa), in Korea.

Alprolix was permitted as a routine prophylactic treatment for inhibition and prevention of bleeding, management before and after surgery (inhibition and prevention of bleeding during surgical procedures), and reduction and prevention of bleeding frequency in patients with hemophilia B.


There are 427 patients with hemophilia B in Korea (as of 2018). Prophylactic treatment, a periodic administration of blood coagulation factors, prevents chronic arthrosis and bleeding in hemophilia patients. So far, for patients with hemophilia B to use conventional standard half-life treatments, 25 to 40 IU/kg of blood coagulation factor had to be dosed intravenously twice a week.

However, since Alprolix (eftrenonacog alfa) has an Fc fusion protein technology that increases the half-life of blood coagulation factor IX by approximately 2.4 times compared to the standard half-life treatment, it became possible to dose only once a week (50 IU/kg) or once every 10-14 days (100 IU/kg). In addition, treatment convenience and quality of life have been improved, and it is expected that pediatric patients who have difficulty in administering injections due to trouble finding veins may benefit.

Alprolix (eftrenonacog alfa) confirmed the effectiveness and safety profile through B-LONG clinical studies. With this treatment, the annual bleeding rate of the prophylactic treatment group decreased significantly compared to the administration group when bleeding occurred. Besides, in a total of 636 bleeding episodes during clinical trials, 97.3% was controlled with only 1 to 2 injections. In B-YOND, the long-term extension study of B-LONG, neutralizing antibodies (inhibitors) were not detected during the four-year study period.

Alprolix (eftrenonacog alfa) introduced a hard case-type package that can store products safely and is easy to carry. The reusable hard case contains a vial, a vial adapter, a pre-filled syringe, and a plunger rod to increase portability, and is designed to safely secure components such as vials that could be easily damaged by external impact.


Copyright © acrofan All Right Reserved