Vivaglobin recently became the first and only FDA-approved subcutaneous immunoglobulin (Ig) treatment and can be safely self-administered by primary immunodeficiency (PI) patients under a physician’s care in the US.
Vivaglobin delivers treatment directly under the skin via a small, portable pump, offering a safe and effective alternative to intravenous (IV) infusions of immunoglobulin. The treatment represents a new treatment option for patients who suffer intolerable side effects from the IV method or whose veins are difficult to access, such as small children.
In the phase III study, 65 patients self-administered Vivaglobin at home every week for 12 months, for a total of 3,655 infusions. The annual rate of serious bacterial infections was 0.04 per patient per year, and the annual rate of any infection was 4.4 episodes per patient per year. No related serious adverse events were reported.
Furthermore, patients in the trial who were assessed for health-related quality of life reported increases in general health and showed a preference for subcutaneous (SC) administration over IV administration.
The new data presented are based on further analysis of the data ZLB Behring submitted to the FDA in seeking marketing approval for Vivaglobin.