FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
GC Biopharma Corp has announced that the U.S. Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “GC5107,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).
Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body’s ability to produce antibodies is impaired, affecting the immune system’s ability to fight infections. In PI, there’s a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G, leading to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. People with PI might experience frequent infections, some of which can be severe or chronic. Treatment often involves immunoglobulin replacement therapy to boost the immune system.
Vaccinations and antibiotics may also be used to prevent and treat infections. The exact type and severity of PI can vary widely among individuals.
