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

Editors Pick
Ford Motor Co. has issued a safety recall for nearly 117,000 vehicles in North America to replace improperly tempered bolts in seats and seatbelts that could fracture. The affected vehicles include 2014 Ford F-150 pickup trucks, 2014 E-Series vans, 2014-15 Ford Escape SUVs and 2015 Lincoln MKC SUVs to replace improperly tempered bolts in seats and seatbelts. Electronics retailer Best Buy is adding Dyson mini-shops to its select stores in the U.S. next month. Dyson is a maker of vacuums, hair dryers, air purifiers and other household items. Starting in August, about 90 U.S. Best Buy stores will get new Dyson Demo Experiences - dedicated spaces that will enable customers try out Dyson products as if they were in their own home. Shares of Airbus Group SE were losing around 4 percent in the morning trading in Paris after the aerospace and defense major reported Thursday a sharp decline in its second-quarter profit with lower revenues. Further, the company maintained its guidance for the full year 2017.
comments powered by Disqus
Follow RTT