Policy & Regulation
GC Pharma submits BLA to US FDA for GC5107
26 February 2021 -

South Korean biopharmaceutical company GC Pharma (KRX:006280) revealed on Thursday that it has submitted its Biologics License Application (BLA) for GC5107 (Immune Globulin Intravenous (Human), 10% Liquid) to the US Food and Drug Administration (FDA).

The company demonstrated positive results in a Phase III study in North America, meeting its primary efficacy endpoint for acute serious bacterial infections (SBI). In trials with PI (Primary Humoral Immunodeficiency) patients, all primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied.

In terms of efficacy, the frequency of SBI was 0.02 for 12 months, satisfying the FDA guidance requirement of no more than one acute serious bacterial infection per person-year. The proportion of infusions with one or more infusion-related AEs was less than 40%.

Following the submission, the FDA has a 60-day filing review period to determine whether the BLA for GC5107 is complete and acceptable for filing.