FDA Approves First Immune Globulin for Subcutaneous Use
January 10, 2006
FDA today announced the approval of the first immune globulin product for subcutaneous injection for the prevention of serious infections in patients with Primary Immune Deficiency Diseases (PIDD). Vivaglobin, manufactured by ZLB Behring GmbH of Marburg, Germany from human plasma collected at U.S. licensed plasma centers, provides new delivery options for PIDD patients. It is given under the skin (subcutaneously) on a weekly basis using an infusion pump, which means patients can self-administer the product at home. Some patients develop problems that make chronic intravenous administration of needed medicines difficult, and Vivaglobin may be helpful in providing them with an alternative route.
PIDD are inherited disorders that affect an estimated 50,000 people in the United States. These patients require regular treatment with immune globulin in order to fight off or prevent potentially serious or life-threatening infections. Other immune globulin products are administered either into the vein (intravenously) or into the muscle (intramuscularly).
"This is an important approval for patients who need lifesaving immune globulin products," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "This new product provides a unique new treatment delivery option to patients and their physicians."
In clinical studies, Vivaglobin was well tolerated. The most common side effect is mild or moderate injection site reaction such as swelling, redness and itching. The contraindications for Vivaglobin are similar to other immune globulin products.
As for all immune globulin preparations, plasma used for Vivaglobin is tested and found to be nonreactive for HIV and hepatitis viruses prior to its use, and the manufacturing process includes steps that further reduce the risk of transmission of viruses.
Posted: January 2006