FDA approves Biotest's BIVIGAM to treat Primary Humoral Immunodeficiency
Published on January 31, 2013 at 9:19 PM
Biotest Pharmaceuticals Corporation (BPC), a wholly owned U.S. subsidiary of Biotest AG, recently announced the U.S. Food and Drug Administration's (FDA) approval of BIVIGAM™, its new intravenous immune globulin, for the treatment of patients with Primary Humoral Immunodeficiency (PI). BIVIGAM is the first new intravenous immune globulin (IVIG) to be approved by the FDA with a validated assay for measuring potential thrombogenic activity. Thrombin generation tests are utilized to detect procoagulant activity. BPC plans to begin shipments of the product shortly.
To reduce the risk of thromboembolic events that PI patients have experienced in the past with alternative products, BPC initiated the development and validation of a TGA test in close cooperation with the FDA. Every lot of BPC's BIVIGAM will be screened before release to assure 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.
BIVIGAM is a sugar-free, glycine stabilized intravenous immune globulin that was approved by the FDA on December 19, 2012 and is available in 50 mL (5 gram) and 100 mL (10 gram) tamper-evident vials. The product uses a label with an integrated hanger and the packaging material is latex free. It is manufactured in a state-of-the-art US facility and will be available exclusively for patients and healthcare professionals in the USA.
Biotest Pharmaceuticals Corporation