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

Study recalculates costs of combination vaccines

14 hours ago

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

18 hours ago

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

Pyridoxine-doxylamine drug safety data lacking

Apr 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

User comments