The FDA has approved immune globulin subcutaneous, human-klhw (Xembify, Grifols) for the treatment of people with primary humoral immunodeficiency (PI) aged two years and older.
Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, as well as rare neurological conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP).
According to the Immune Deficiency Foundation, approximately 250,000 individuals have PI in the U.S., and thousands more remain undiagnosed.
Primary immunodeficiency diseases are a group of more than 350 rare, chronic disorders in which part of the immune system is either missing or functions improperly. The diseases, which are not contagious, are caused by hereditary or genetic defects. Some disorders present at birth or during early childhood, and they can affect anyone regardless of age or gender.
Patients with PI usually have an increased susceptibility to infection, which can occur in the skin, sinuses, throat, ears, lungs, brain or spinal cord, or in the urinary or intestinal tracts. People with the condition often develop serious and debilitating illnesses.
The company plans to introduce Xembify in the U.S. in the last quarter of 2019.