The U.S Food and Drug Administration approves Rixubis, the first recombinant coagulation factor IX, particularly designed help prevent bleeding episodes.
Hemophilia B patients 16 years old and above can now use this drug to control and prevent bleeding episodes, to manage condition during surgery and even after hospital discharge, and routine use to prevent or lessen the occurrence of bleeding episodes or prophylaxis.
Hemophilia B is a rare blood disorder caused by factor IX gene which was said to have genetically affected the royal families of Great Britain, Russia, Germany, and Spain. In the U.S, about 3,300 people were affected. A patient with this disease may suffer from severe bleeding on the joints or muscles.
“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,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research on the press release. “This approval provides patients and physicians with an alternative treatment option to prevent or reduce the frequency of bleeding episodes.”
Rixubis is a purified protein produced by recombinant DNA technology manufactured by California-based Baxter Healthcare Corporation. However, it doesn’t have human or animal proteins. Patients may be given this treatment twice a week by a doctor by mixing the powdered drug with sterile water before administering it through intravenous injection.
Rixubis was assessed in a study in which 73 male patients with age between 23 and 65 years old. The researchers wanted to make sure that it can effectively help patients with routine prophylaxis or those suffering with continuous bleeding. Their evaluation revealed that patients who used the drug had 75 percent lower rate of bleeding compared to those who received treatments only when there is an episode of bleeding. The researchers are now testing if the drug can be administered to pediatric patients as well.
