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 genetic disorder do not make enough Factor XIII, a blood component that promotes clotting. Tretten, a human recombinant produced in yeast cells, 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.
Explore further: FDA approves rixubis for prophylactic tx in hemophilia B
More information: To learn more about this disorder, visit the National Hemophilia Foundation.
Copyright © 2013 HealthDay. All rights reserved.
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© Medical Xpress 2011-2013, Science X network
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 genetic disorder do not make enough Factor XIII, a blood component that promotes clotting. Tretten, a human recombinant produced in yeast cells, 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.
Explore further: FDA approves rixubis for prophylactic tx in hemophilia B
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Copyright © 2013 HealthDay. All rights reserved.
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Jun 28, 2013
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Dec 19, 2013
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