BIVIGAMâ¿¢ [Immune Globulin Intravenous (Human), 10% Liquid] Is The First New IVIG Product Approved With A Validated And FDA Approved Thrombin Generation Assay (TGA) Test
BOCA RATON, Fla. and DREIEICH, Germany, Jan. 31, 2013 /PRNewswire/ -- 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. For Full Prescribing Information and more information about the product, the indication and additional services, please visit www.BIVIGAM.com.
For ordering information, please contact our customer support at 1.800.458.4244 and select Option 1.Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
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