Investigational IVIG Product Under Review for Primary Immunodeficiency

The Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for GC5107B (immune globulin intravenous [human]) for patients with primary humoral immunodeficiency (PI).

GC5107B is a liquid solution containing 10% immunoglobulin G (100mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The application includes data from an open-label, single-arm, historically controlled, multicenter phase 3 study (ClinicalTrials.gov Identifier: NCT02783482) that evaluated the efficacy and safety of GC5107B in 49 patients aged 3 to 70 years with a confirmed diagnosis of PI. The primary endpoint of the study was the incidence of acute serious bacterial infections (aSBI).

Findings showed an incidence of 0.02 aSBI events per patient-year (FDA’s efficacy requirement is <1 aSBI per patient-year). Moreover, the study met all secondary efficacy endpoints, which were comprised of the number of days absent from work or school due to an infection (mean of 7.1 days), hospitalization due to infection (mean of 0.1 days), and days of unscheduled visits to a physician (mean 2.3 days). All were considered low and comparable to results seen with other IVIG products. The most common treatment-related adverse events reported were headache, fatigue, and nausea.

A Prescription Drug User Fee Act target date of January 13, 2024 has been set for the application.

This article originally appeared on MPR