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.
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
AstraZeneca announces US approval for Ultomiris for NMOSD treatment