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.
EU Commission decides not to renew AstraZeneca and J&J COVID-19 vaccine contracts next year
Publix suspends administration of Johnson & Johnson COVID-19 vaccine based on CDC and FDA guidance
Publix suspends administration of Johnson & Johnson COVID-19 vaccine based on CDC and FDA guidance
SAGE-324 Phase 2 Placebo-Controlled KINETIC Study in Essential Tremor Met Primary Endpoint
Frankel Named to Precision BioSciences B oard of Directors
Sobi launches phase 3 trial of efanesoctocog alfa in children with haemophilia A