GC Pharma BLA for Humoral Immunodeficiency

GC Pharma has submitted a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral immunodeficiency disease. The submission is based on data from a Phase 3 North America study that met its primary efficacy endpoint on the incidence rate of acute serious bacterial infections, the company says. All primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied, it adds.

GC Pharms says that the frequency of serious bacterial infections was 0.02 for 12 months, which satisfied an FDA requirement of no more than one acute serious bacterial infection per person-year. The proportion of infusions with one or more infusion-related adverse event was less than 40%, which also met the primary safety endpoint.

The submission is currently undergoing an FDA 60-day filing review to determine whether the BLA is complete and acceptable for filing.