Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Baxter International Inc. (BAX: Quote) 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.

Click here to receive FREE breaking news email alerts for Baxter International Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks saw some volatility following the release of the Federal Reserve's monetary policy announcement on Wednesday but managed to end the day modestly higher. With the upward move, the Dow reached a new record closing high. President Barack Obama sought to emphasize in remarks on Wednesday that the American forces being deployed as part of the fight against the terrorist group ISIS will not have a combat mission. Republican Joni Ernst has moved into the lead in the potentially crucial Iowa Senate race, according to the results of a Quinnipiac University poll released on Wednesday. The poll found that 50 percent of likely Iowa voters would support Ernst if the election were held today, while 44 percent would vote for Democratic Rep. Bruce Braley.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.