Green Cross announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G), for the treatment of primary immunodeficiency diseases (PID).
The BLA submission is supported by positive data from a Phase 3 study of IVIG-SN in patients with PID. In the study, IVIG-SN achieved its primary endpoint of no acute bacterial infections, which is well under the FDA requirement of no more than 1 acute serious bacterial infection per patient-year.
The FDA has scheduled a Prescription Drug User Fee Act (PDUFA) action date for the 4th quarter of 2016 to complete the review.
For more information visit Greencross.com.