Tretten approved for genetic clotting disorder

by Scott Roberts, Healthday Reporter

(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.

People with the do not make enough Factor XIII, a blood component that promotes clotting. Tretten, a human recombinant produced in , makes up for this deficiency, which could otherwise be life threatening, the FDA said Monday in a news release.

Tretten was evaluated in a clinical study of 77 people with the disorder. Administered monthly, it was effective in preventing bleeding in 90 percent of recipients. Side effects included headache, extremity pain and pain at the injection site. No study participant developed abnormal clotting, the FDA said.

The product was developed and is produced by Novo Nordisk, based in Denmark.

More information: To learn more about this disorder, visit the National Hemophilia Foundation.

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 ...

Stent to treat pancreatic cysts approved

Dec 19, 2013

(HealthDay)—The Axios Stent and Delivery System has been approved by the U.S. Food and Drug Administration to treat infected pancreatic cysts that won't drain on their own and could become life threatening, the FDA said ...

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 ...

Octaplas approved for blood-clotting disorders

Jan 17, 2013

(HealthDay)—Octaplas has been approved by the U.S. Food and Drug Administration to augment insufficient clotting proteins that could otherwise lead to excessive bleeding or excessive clotting.

Recommended for you

FDA OKs Cubist antibiotic for serious infections

14 hours ago

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

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.