US FDA Accepts Green Cross' Biologics License Application For IVIG-SN
YONGIN, South Korea, Jan. 25, 2016 /PRNewswire/ -- Green Cross Corporation (Green Cross) (KRX: 006280), a South Korean biopharmaceutical company, today announced that the United States Food and Drug Administration (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.
"The expected introduction of IVIG-SN will provide meaningful immune globulin product option for clinicians and their patients that further builds on the success already achieved with our products in other parts of the world," said EC Huh, Ph. D., President of Green Cross Corporation. "IVIG-SN marks a major step towards our ultimate goal of expanding biologics business to the US marketplace."
Green Cross, the largest plasma protein products manufacturer in Asia, has been marketing IVIG-SN in more than 30 countries in Asia, South America and Middle East.
About Green Cross Corporation
Green Cross Corporation (Green Cross) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, Green Cross is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for nearly half a century.
About Primary Immunodeficiency Disease (PID)
PID is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. PID patients are more vulnerable to infections and more likely to suffer complications from these infections. According to the World Health Organization, there are over 150 different presentations of PID.
This release includes forward-looking statements, which express the current beliefs and expectations of management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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SOURCE Green Cross