FDA approves rixubis for prophylactic tx in hemophilia B

(HealthDay)—Rixubis (coagulation factor IX recombinant) has been approved by the U.S. Food and Drug Administration to prevent routine bleeding episodes in people aged 16 and older with hemophilia B, the agency said in a news release.

It's the first recombinant coagulation factor IX to be sanctioned by the FDA. People with B, mostly males, have a that leads to a deficiency in factor IX. Affecting some 3,300 people in the United States, the disorder can cause serious bleeding episodes, most commonly affecting the joints, the agency said.

Rixubis is a purified protein supplied as a freeze-dried powder. It is injected twice weekly after being combined with sterilized water.

The treatment was evaluated in clinical studies involving 73 males between the ages of 12 and 65. Those who received the treatment had a 75 percent lower annual bleeding rate than those who had historically received on-demand treatment, the FDA said.

The treatment may lead to life-threatening in some recipients, the agency warned. More common clinical side effects included distorted taste, extremity pain, and atypical blood test results.

Rixubis is produced by Baxter Healthcare, based in Westlake Village, Calif.

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

Simponi approved for ulcerative colitis

May 15, 2013

(HealthDay)—Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

Xgeva approved for rare, non-malignant tumor

Jun 13, 2013

(HealthDay)—Xgeva (denosumab) has been approved by the U.S. Food and Drug Administration to treat giant cell tumor of the bone (GCTB), a rare tumor that's most often non-cancerous.

Kcentra approved to stop severe bleeding in heart patients

Apr 30, 2013

(HealthDay)—Kcentra (prothrombin complex concentrate, human) has been approved by the U.S. Food and Drug Administration to treat severe acute bleeding in adults after administration of the anti-clotting drug warfarin and ...

Recommended for you

Drug research and development more efficient than expected

Feb 27, 2015

Drug R&D costs have increased substantially in recent decades, while the number of new drugs has remained fairly constant, leading to concerns about the sustainability of drug R&D and question about the factors that could ...

Use new meningitis vaccines only for outbreaks

Feb 26, 2015

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

Feb 26, 2015

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.