First Commercially Available Intravenous Immune Globulin with a Thrombin Generation Assay Test - Pharmaceutical Technology

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First Commercially Available Intravenous Immune Globulin with a Thrombin Generation Assay Test



Biotest Pharmaceuticals Corporation announced that Bivigam [immune globulin intravenous (human), 10% liquid] is now available in the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the US. Bivigam is a sugar-free, glycine stabilized intravenous immune globulin that has been approved by the FDA in December 2012 for the treatment of patients with primary humoral immunodeficiency (PI). The product is available in 50 mL (5 grams) and 100 mL (10 grams) tamper-evident vials.

This is the first new intravenous immune globulin (IVIG) approved in the US, with a validated assay for measuring potential thrombogenic activity. Thrombin generation tests are used to detect procoagulant activity.

Biotest has developed and validated the thrombin generation assay (TGA) test in close cooperation with the FDA to help reduce the risk of thromboembolic events that PI patients experienced with alternative products in the past. Each lot of Bivigam will be screened before release to ensure that the product fulfills the stringent release criteria pertaining to the threshold levels of Factor XIa. Increased Factor XIa has been identified as one of the risk factors associated with thromboembolic events following immune globulin intravenous therapy.

Biotest has made significant investments in its infrastructure and ability to efficiently manufacture and deliver the product to best serve the US market and patient population. The company has invested more than $50 million to enhance the capacity of its protein purification facility in Boca Raton, Florida.

“The FDA approval and first commercial sales of Bivigam are key corporate milestones for Biotest. The expansion and enhancement of our manufacturing capabilities have positioned us strongly to meet current and future patient and market demand,” Jordan Siegel, CEO of Biotest, said in a press statement. “We are committed to supporting PI patients with Bivigam to ensure their uncompromised living.”

Full prescribing information and more information about the product, the indication and additional services can be found at www.bivigam.com.

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