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

FDA approves hard-to-abuse narcotic painkiller

10 hours ago

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

10 hours ago

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

11 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

11 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments