Blood clotting disorder treatment approved for use in US

Hannah Blake

pharmaphorum

A pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels has been approved for use in the US by regulatory body, the FDA.

Octaplas, developed by Austrian pharma company Octapharma, is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from US donors who have been screened and tested for diseases transmitted by blood, and determined to be suitable donors.

“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, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

A previous generation of Octaplas, first marketed in 1992, has been used extensively in Europe and other countries. Over 2 million patients have been treated with over 7 million doses of Octaplas outside of the US.

The FDA’s approval of Octaplas for use in the United States was primarily based on clinical trials conducted in patients with liver disease, liver transplant, heart surgery and TTP. However, the FDA also looked at additional data supporting the safe use of Octaplas for the US market.