IVIG SN (immunoglobulin G intravenous) filed with FDA for primary immunodeficiency diseases- Green Cross

Green Cross Corporation announced that the FDA has accepted for review the Company's Biologics License Application for IVIG SN (human normal immunoglobulin G for intravenous administration) intended for the treatment of primary immunodeficiency diseases (PID), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete the review is scheduled for the fourth quarter of 2016.

IVIG-SN demonstrated positive results in a Phase III study in patients with PID, meeting its primary endpoint of no acute serious bacterial infections. These results, included in the submission, were well under the requirement specified by the FDA guidance of no more than one acute serious bacterial infection per patient-year.