Primary Humoral Immunodeficiency Patients Obtain Treatment Option

GC Biopharma today announced that the U.S. Food and Drug Administration (FDA) accepted the Company's resubmission of the Biologics License Application for its GC5107B (Immune Globulin Intravenous) for patients with primary humoral immunodeficiency (PI).

GC5107B is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from U.S. donors.

The FDA's Prescription Drug User Fee Act target action date is January 13, 2024. If approved, GC Biopharma could provide more treatment options for patients with PI in the U.S. next year.

PI disease comprises a large, heterogeneous group of disorders resulting from inborn errors of immunity.

Patients with PI cannot mount an immune response to pathogens and can experience recurrent bacterial, viral, fungal, and protozoal infections as a result.

As of July 31, 2023, global estimates project that up to six million people may live with PI.

While the U.S. immunoglobulin market size is estimated at US$ 10.4 billion in 2022, there have been sporadic shortages, says GC Biopharma. The manufacturing process includes three steps to reduce the risk of virus transmission.

Note: Immune Globulin Intravenous products are not preventive vaccines.