FDA Approves New Treatment to Help Patients With Primary Immunodeficiencies

In January, 2006, the US Food and Drug Administration (FDA) approved Vivaglobin, an immunoglobulin (Ig) replacement therapy designed to help treat patients with primary immunodeficiency (PI). Vivaglobin is manufactured and marketed by ZLB Behring. Vivaglobin is designed to deliver treatment directly under the skin (subcutaneously), and ZLB Behring says it offers a safe and effective alternative to intravenous infusions of immunoglobulin (IVIG). An estimated 50,000 Americans have PI, and the new treatment may be another option for patients who have poor venous access or experience serious side effects from IVIG. ZLB Behring says that Vivaglobin can be safely self-administered by PI patients under a physician's care and that it is the only FDA-approved subcutaneous Ig treatment in the United States.