Long-acting clotting agent approved for form of hemophilia

March 31, 2014

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.

Explore further: FDA approves rixubis for prophylactic tx in hemophilia B

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

Related Stories

FDA approves rixubis for prophylactic tx in hemophilia B

June 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

December 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

December 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 A, a serious and ...

Gene therapy helps patients with hemophilia B

December 13, 2011

(Medical Xpress) -- An experimental gene therapy technique boosted the production of a vital blood clotting factor in six people with hemophilia B, according to new research supported by the National Institutes of Health. ...

Recommended for you

Universal flu vaccine designed by scientists

September 30, 2016

An international team of scientists have designed a new generation of universal flu vaccines to protect against future global pandemics that could kill millions.

0 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.