The U.S. Food and Drug Administration on Thursday announced their approval of a new coagulant that helps control and prevent bleeding episodes for those with hemophilia B.
Hemophilia B is an inherited blood clotting disorder caused by a gene mutation that affects more men than women. The disorder causes a deficiency in "Factor IX," which in hemophilia B leads to serious bleeding, mainly into the joints, which can be destroyed by such bleeding, according to the FDA.
The new hemophilia B drug, Rixubis, is for the use of people 16-years of age and older. An additional study for use in younger patients suffering from the disorder is ongoing. The medication helps to control and prevent "bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes," the FDA stated in their press release.
"As the first recombinant coagulation factor IX indicated specifically for routine prophylaxis to prevent bleeding, Rixubis becomes a new weapon in our arsenal to protect Hemophilia B patients," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in the press statement. "This approval provides patients and physicians with an alternative treatment option to prevent or reduce the frequency of bleeding episodes."
According to the FDA, Rixubis is a "purified protein produced by recombinant DNA technology." The drug does not contain protein from humans or animals.
Rixubis comes in single-use vials in a powder form. The medication is prepared with sterile water and is administered through intravenous injection. It's administered twice a week when used for routine prevention of bleeding episodes.
"Although serious side effects including anaphylaxis (life-threatening allergic reactions) can occur, the most common side effects observed in patients in clinical studies were dysgeusia (distorted taste), pain in an extremity, and atypical blood test results," the FDA said.
