Green Cross Files BLA for Immunodeficiency Diseases

South Korea-based Green Cross Corp. has filed a BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), indicated for treating primary immunodeficiency diseases (PID). The company expects a user fee review target in the fourth quarter.

The submission is based on Phase 3 data that demonstrated positive results and met 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 company says.

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, according to the company. PID patients are more vulnerable to infections and more likely to suffer complications from these.