BIVIGAM™ [Immune Globulin Intravenous (Human), 10% Liquid] is the First New IVIG Product Approved with a Validated and FDA Approved Thrombin Generation Assay (TGA) Test
01/31/2013 4:30 pm
Boca Raton, Florida and Dreieich, Germany, January 31, 2013 – 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.
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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.
About Biotest AG
Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of clinical immunology, haematology and intensive medicine. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
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About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation was created as a wholly-owned US subsidiary of Biotest AG in December 2007. Innovative technologies and a sharp focus on safety are incorporated into every facet of the business. From plasma collection to product manufacturing and distribution – from nature for life – Biotest Pharmaceuticals Corporation is committed to maintaining high standards of excellence. With further questions, please contact the Customer Support at 1-800-458-4244