FDA approves ZLB Behring's Vivaglobin for PIDD

The US Food and Drug Administration has approved the first immune globulin product for subcutaneous injection for the prevention of serious infections in patients with Primary Immune Deficiency Diseases. Vivaglobin, which is manufactured by ZLB Behring GmbH of Marburg, Germany, from human plasma collected at US licensed plasma centers, provides new delivery options for PIDD patients. It is given 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, the FDA noted, adding that, this family of inherited disorders affects an estimated 50,000 people in the USA.