logo
Share SHARE
FONT-SIZE Plus   Neg

Baxter: FDA Approves Rixubis For Routine Prophylactic Treatment In Hemophilia B

Baxter International Inc. (BAX) said the United States Food and Drug Administration has approved Rixubis for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B.

Rixubis is the first new recombinant factor IX or rFIX approved for hemophilia B in more than 15 years. It is the only rFIX indicated for both routine prophylaxis and control of bleeding episodes in the U.S. for adult patients living with this chronic condition.

Hemophilia B is the second most common type of hemophilia. It is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding.

The approval is based on a Phase I/III study demonstrating that twice-weekly prophylactic treatment with Rixubis for six months achieved a median annualized bleed rate or ABR of 2.0 with 43 percent of patients experiencing no bleeds.

In this study, no patients developed an inhibitory antibody to FIX and no cases of anaphylaxis were reported. One patient developed a transient antibody to furin.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Apple Inc. has confirmed that the iPhone 6s battery issue may be larger than thought, as the tech giant said that some customers "outside the affected range of devices" have also reported unexpected shutdowns. The company again stressed that it is not a security issue. Tesla Motors Inc. voluntarily recalled more than 7000 charging adapters. The company said these adapters of Nema 14-30, 10-30 and 6-50 are sold separately as accessories. Earlier in November, two customers had complained about overheating issue of Nema 14-30 charging adapters. Tesla confirmed in its recall communication that there were no other similar incidents or reports of injuries or proper Sony announced Project Field, a new play way to bring card games to life, along with a host of smartphone games at an event in Japan, aiming to accelerate mobile drive. Project Field is a Japan-only card collection platform where actual physical cards will work with a smartphone app. The first title to be announced is based on Yo-kai Watch for mobile. There is no news about an international releas
comments powered by Disqus
Follow RTT