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news.Green Cross has submitted its biologics license application for IVIG-SN (human normal immunoglobulin G for intravenous administration) to the US Food and Drug Administration (FDA).
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The application submitted 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.
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 1 acute serious bacterial infection per patient-year.
Green Cross president EC Huh said: "The BLA submission for IVIG-SN marks a major step towards our ultimate goal of expanding biologics business to the US marketplace.
"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."
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.
The FDA has a 60-day filing review period to determine whether Green Cross’ Biologics License Application for IVIG-SN is complete and acceptable for filing.