CSL Behring Korea said Monday that the Ministry of Food and Drug Safety has approved its albumin recombinant factor 9, IDELVION (Ingredient: Albutrepenonacog), as hemophilia B treatment for children and adults.
IDELVION is a recombinant albumin factor 9 with an extended half-life that fuses blood coagulation factor 9 with albumin to stop the bleeding. The indication is to control and prevent bleeding and perioperative management of children and adults who have coagulation factor 9 deficiency. The drug cannot be used as an immunotolerance therapy, however.
For conventional preventive therapy, the injection of 35 to 50 international units per kilogram is recommended once a week. Adults and children aged 12 or above who are well-controlled with ordinary therapy can take 75 international units per kilogram in a 10- or 14-day interval.
According to the PROLOG-9FP study, the group that administered 75 international units per kilogram of IDELVION once in 14 days maintained a 5 percent increase in active figure of coagulation factor 9 and recorded an average of zero rates in annualized spontaneous bleeding.
IDELVION acquired approvals from the U.S., Europe, Japan, and Canada in 2016.
"We are pleased to further strengthen our expertise in the hemophilia field that CSL Behring is showing innovative genetic recombination technology, following the introduction of Abstilla and Idelbion in February," CSL Behring Korea Manager Sohn Ji-young said.
She added that IDELVION is the company’s first recombinant drug to get approval from the U.S. Food and Drug Administration.
"We expect IDELVION will bring about a groundbreaking change in hemophilia B patients' lives in Korea as the drug had been verified overseas," Sohn said.
Hemophilia B patients are mostly men who have coagulation factor 9 deficiency or congenital bleeding disorders caused by the defect. More severe hemophilia B patients frequently experience bleeding without injury apart from usual light bleeding. They can also have a natural hemorrhage in the joint, skeletal muscle, and organs for a long time without stopping. Hemophilia is the most severe hemorrhagic disease. Currently, 2,400 Hemophilia patients are registered in Korea, and 400 of them have the B type.
CSL Behring also runs CSL Plasma, one of the largest plasma-collecting networks in the world.
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