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FDA Accepts Application for IV Immunoglobulin

Approval review scheduled for late 2016

The FDA has accepted for review a biologics license application for IVIG-SN (human normal immunoglobulin G for intravenous administration, Green Cross Corporation) intended for the treatment of primary immunodeficiency diseases (PIDs).

The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review has been scheduled for the fourth quarter of 2016.

IVIG-SN demonstrated positive results in a phase 3 study in patients with PID, meeting its primary endpoint of no acute serious bacterial infections. These results, included in the FDA submission, were well under the requirement specified by the agency’s guidance of no more than one acute serious bacterial infection per patient-year.

PIDs are inherited genetic disorders that cause individuals to have a deficient or absent immune system because of either a lack of necessary antibodies or a failure of these antibodies to function properly. PID patients are vulnerable to infections and are more likely to experience complications from those infections. According to the World Health Organization, there are more than 150 different presentations of PID.

Headquartered in South Korea, Green Cross Corporation is the largest plasma-protein product manufacturer in Asia.

Source: Pipeline Review; January 25, 2016.

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