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
Media conglomerate Viacom, Inc. on Tuesday reported a 10 percent decline in profit for the first quarter from last year, reflecting lower revenues in the Filmed Entertainment and Media Networks segments. However, adjusted earnings per share for the quarter matched analysts' expectations, while revenues missed their estimates. Transmission utility ITC Holdings Corp. announced Tuesday that it has entered into an agreement and plan of merger to be acquired by Canadian electric and gas utility company Fortis Inc. in a deal valued at approximately $11.3 billion. ITC shareholders will receive $22.57 in cash and 0.7520 Fortis shares per ITC share. The Coca-Cola Company (KO) reported that its fourth-quarter net income to shareowners increased to $1.24 billion or $0.28 per share from $770 million or $0.17 per share, last year. Adjusted earnings per share was $0.38, for the quarter. On average, 21 analysts polled by Thomson Reuters expected the company...
comments powered by Disqus
RELATED NEWS
Trade BAX now with 
Follow RTT