CSL Behring announced that the US Food and Drug Administration (FDA) has granted marketing approval for Privigen [Immune Globulin Intravenous (Human), 10 per cent Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.
A 10 per cent liquid preparation of polyvalent human immunoglobulin, Privigen offers healthcare professionals convenience and ease-of-use. It is the first and only proline-stabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution.
"Privigen is an exciting new offering to patients and healthcare professionals in the United States," said Paul Perreault, executive vice president of Worldwide Commercial Operations at CSL Behring. "As the leader in developing safe, high-quality, effective immune globulin therapies for use around the world, CSL Behring is proud to add yet another product to our rapidly growing portfolio. We see a strong demand for Privigen and are pleased to be bringing it to patients and other valued customers."
"With Privigen, once again, CSL Behring has answered an important need," said Mark Stein, M.D., Chief, Allergy Section at Good Samaritan Hospital in West Palm Beach Hospital in Florida. "The time savings and flexibility it provides to healthcare professionals is an important step forward. It will certainly be a welcome addition to currently available immune globulin therapy options in the US." Dr. Stein served as lead investigator on the Privigen clinical trial.
CSL Behring plans to launch Privigen in the first quarter of 2008. In the meantime, the company is advancing the registration of Privigen in Europe. The application is currently under review by European regulatory authorities.
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services.