The U.S. Food and Drug Administration (FDA) has approved the United States' first-ever coagulation factor-albumin fusion protein product.
Idelvion, coagulation Factor IX (recombinant), an albumin fusion protein, is indicated for adult and pediatric patients living with hemophilia B, an inherited bleeding disorder marked by the blood's inability to clot normally. Men are more often diagnosed with the disease, which can cause serious bleeding in the joints.
“The approval of Idelvion provides another important therapeutic option for children and adults with hemophilia B to help prevent or control bleeding, and reduce the frequency of bleeding episodes,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.
Idelvion works by replacing Factor IX, a clotting factor found in the blood. Because it is given intravenously, it lasts longer in the blood. It is to be used on an as-needed basis to control and prevent bleeding episodes or to manage bleeding after surgery.
The drug was the subject of two multi-center studies that included 90 hemophilia B patients between the ages of 1 and 61. It proved effective in the control of bleeding related to both hemophilia B and surgery.
