Green Cross announced that it has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for IVIG-SN (human normal immunoglobulin G) for the treatment of primary immunodeficiency diseases (PID).
The submission is based on positive results from a Phase 3 study which demonstrated that IVIG-SN met its primary endpoint of no acute bacterial infections in patients with PID. These results were well under the FDA requirement of no more than 1 acute serious bacterial infection per patient-year.
Green Cross has been marketing IVIG-SN in more than 30 countries in Asia, South America and Middle East.
For more information visit Greencross.com.