GC Pharma (006280.KS) today announced that it had submitted its Biologics License Application (BLA) for ‘GC5107’ (Immune Globulin Intravenous (Human),10% Liquid) to the United States Food and Drug Administration (FDA).
GC Pharma demonstrated positive results in a Phase III study in North America, meeting its primary efficacy endpoint of acute serious bacterial infections (SBI). In the trials included in the submission, with PI (Primary Humoral Immunodeficiency) patients, all primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied.
