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.
Lilly's Foundayo (orforglipron) weight loss pill gains US FDA approval
Abbisko Therapeutics' FGFR4 inhibitor irpagratinib granted orphan designation in Europe for HCC
US FDA approves i-Lumen Scientific's i-SIGHT2 clinical study for dry AMD
Lilly to acquire Centessa Pharmaceuticals for up to USD47 per share
ALK secures EU approval for EURneffy 1 mg as needle-free adrenaline option for children
Sanofi secures EU approval for Rezurock in chronic graft-versus-host disease
Boston Scientific receives FDA clearance for Asurys fluid management system
Aurinia Pharmaceuticals agrees to acquire Kezar Life Sciences
Rocket Pharmaceuticals secures FDA approval for Kresladi gene therapy in severe LAD-I
Pharming receives positive CHMP opinion for Joenja marketing authorisation
Biocytogen partner NEOK Bio secures FDA IND clearance for cancer therapy candidate
Eisai and Nuvation Bio report taletrectinib MAA validated by European regulator
Novo Nordisk's Awiqli once-weekly basal insulin treatment approved by US FDA