Germany-based ZLB Behring has won approval in the USA for Vivaglobin, the first immune globulin (Ig) product for primary immune deficiency that can be delivered by subcutaneous injection.
Vivaglobin has been approved by the Food and Drug Administration for preventing serious infections in patients with primary immune deficiency diseases (PIDD), a group of disorders that require sufferers to receive lifelong doses of Ig in order to stop them succumbing to infections. PIDD affect around 50,000 people in the USA.
At present, all Ig products on the US market have to be delivered intravenously or by intramuscular injection. In contrast, Vivaglobin is given under the skin using a pump once a week, which for the first time makes it feasible for patients to self-administer treatment at home.
Vivaglobin has already been approved in a number of European countries and a market application in Canada is currently under review, according to ZLB Behring, which was formerly part of Aventis and was sold to Australian group CSL in 2004.