Baxter announced that the FDA has approved Rixubis (coagulation factor IX [recombinant]) for routine prophylaxis, control of bleeding episodes, and perioperative management in adults with hemophilia B.
Rixubis is the first new recombinant factor (rFIX) approved for hemophilia B in more than 15 years and is the only rFIX indicated for both routine prophylaxis and control of bleeding episodes.
The FDA approval is based on data from a Phase I/III prospective, open-label, uncontrolled, multicenter study that evaluated the pharmacokinetics, efficacy, and safety of Rixubis in previously-treated patients with severe or moderately severe hemophilia B. Study results showed that twice weekly prophylactic treatment with Rixubis for six months achieved a median annualized bleed rate (ABR) of 2.0 with 43% of patients experiencing no bleeds.
Rixubis will be available in 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU dosage strengths in single vials. A Baxject II Needle-less Transfer device will be included in each package.
For more information call (800) 4-BAXTER or visit www.baxter.com.