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FDA Approves IVIG Product Bivigam With Thrombogenic Assay

First IVIG approved with test to detect procoagulant activity (Jan. 31)

The FDA has approved Bivigam (Biotest Pharmaceuticals) intravenous immune globulin (IVIG) for the treatment of patients with primary humoral immunodeficiency in conjunction with a validated assay for measuring potential thrombogenic activity. Thrombin-generation tests are used to detect procoagulant activity.

To reduce the risk of thromboembolic events that patients with primary humoral immunodeficiency have experienced with alternative products, the developer of Bivigam created and validated a thrombin-generation assay (TGA) test in cooperation with the FDA. According to the drug’s developer, each lot of Bivigam will be screened before release to assure that the product meets stringent criteria pertaining to threshold levels of factor XIa. Increased factor XIa has been identified as a risk factor associated with thromboembolic events following IVIG therapy.

Bivigam is a sugar-free, glycine-stabilized IVIG that was originally approved by the FDA in 2012. It is available in 50-mL (5-gram) and 100-mL (10-gram) tamper-evident vials.

Sources: Biotest Pharmaceuticals; January 31, 2013; and Bivigam PI; April 2012.

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