CSL Behring has officially launched Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] to combat blood clotting disorder Hemophilia B. This is the pioneering and only existing factor IX therapy that is permits up to 14-day dosing in some patients aged more than or equal to 12 old.
The new drug, which was approved by the US Food and Drug Administration on March 4, 2016, is compatible both in adults and children suffering from hemophilia B. It can be used for routine prophylaxis to lessen frequency of bleeding episodes; for on-demand control and prevention of bleeding instances; and for perioperative management of bleeding, according to PR Newswire
“Idelvion provides excellent bleeding control by maintaining factor IX activity levels above 5 percent over a prolonged period of time, resulting in a median annualized spontaneous bleeding rate of zero,” Dr. Jerry Powell of North America Commercial Operations of CSL Behring said. “We are proud to offer this long-acting therapy as a part of our broad portfolio of bleeding disorder products and are particularly excited about the positive impact Idelvion can have on the lives of patients with hemophilia B.”
The drug will be commercially available on four different vial sizes: 250 IU, 500 IU, 1000 IU and 2000 IU and may be stored in the fridge or at room temperature.
Hemophilia B, also known as Christmas disease, is a genetic condition caused by insufficient or defective clotting protein called factor IX. Commonly, the disease is passed down from parents, but some one-third of cases result from spontaneous mutation or a change in a gene.
People suffering from hemophilia tends to have a longer bleeding time compared with other people. Bleeding can happen both internally, including joints and muscles, and externally, such as dental procedures and trauma.
One in every 5,000 live births are affected by hemophilia B, according to the US Centers for Disease Control and Prevention. In the Unites States alone, there are approximately 20,000 cases reported, and all races and ethnic groups can be affected