Long-acting clotting agent approved for form of hemophilia

The drug Alprolix has been approved by the U.S. Food and Drug Administration as the first long-acting hemophilia B clotting agent, the FDA said in a news release.

The product, formally known as "coagulation factor IX recombinant Fc Fusion protein" is the first B remedy designed to require less frequent injections than prior treatments, the FDA said. It was approved to help control and prevent bleeding episodes and to manage bleeding during surgery.

Hemophilia B is a blood-clotting disorder, primarily affecting males, caused by an abnormal Factor IX gene. Affecting some 3,300 people in the United States, it can lead to potentially deadly bleeding episodes.

Alprolix was evaluated in clinical studies involving 123 people, ages 12-71, with severe hemophilia B. No safety issues were identified during the trials, the FDA said.

The product is manufactured by Biogen Idec, located in Cambridge, Mass.

More information: Visit the National Hemophilia Foundation to learn more about this disorder.

add to favorites email to friend print save as pdf

Related Stories

FDA approves rixubis for prophylactic tx in hemophilia B

Jun 28, 2013

(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 ...

Tretten approved for genetic clotting disorder

Dec 23, 2013

(HealthDay)—Tretten (coagulation factor XIII A-Subunit recombinant) has been approved by the U.S. Food and Drug Administration to treat a very rare blood clotting disorder called congenital Factor XIII A-Subunit deficiency.

New gene therapy targets hemophilia

Dec 11, 2013

Researchers at the UNC School of Medicine and the Medical College of Wisconsin found that a new kind of gene therapy led to a dramatic decline in bleeding events in dogs with naturally occurring hemophilia ...

Recommended for you

Supermaterial gives rejected drugs a new chance

20 hours ago

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

Ruconest approved for rare genetic disease

Jul 17, 2014

(HealthDay)—Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal ...

NIH system to monitor emerging drug trends

Jul 17, 2014

An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased ...

User comments