FDA Okays Blood Plasma Product for Clotting Disorders

Disclosures

January 17, 2013

A blood plasma product long used in Europe and other parts of the world to treat clotting disorders was approved today by the US Food and Drug Administration (FDA) for use in the United States.

The product, Octaplas (Octapharma), is a frozen solution of pooled human plasma that replaces clotting proteins that are present at insufficient levels in certain medical conditions. Such deficiencies can cause excessive clotting or bleeding.

The new product resembles fresh-frozen plasma except that it contains human plasma from several donors, not just one. It is treated with a solvent detergent that kills certain viruses, minimizing the risk for infection.

In the United States, the manufacturer will collect plasma from US donors who have been screened and tested for blood-borne diseases.

"For patients suffering with clotting disorders, this product provides a viable alternative to single-donor Fresh-Frozen Plasma and provides a reduced risk of certain viral transmissions," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.

The first generation of Octaplas hit the world market in 1992. The current version has been available since 2006.

The FDA based its decision to approve Octaplas for marketing in the United States primarily on clinical studies of patients with liver disease, liver transplant, heart surgery, and thrombotic thrombocytopenic purpura. The agency also looked at safety data derived from prior use of the product in Europe and other approved markets. In Europe, it was not associated with transfusion-related acute lung injury, which is an infrequent but serious transfusion risk involving single units of plasma.

Shortness of breath, dizziness, chest discomfort, skin itchiness and rashes, headache, and tingling sensations were the most common adverse reactions observed in clinical studies.

More information about today's approval of Octaplas is available on the FDA Web site.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....