Xembify Approved to Treat Primary Immunodeficiency
July 3, 2019 – The U.S. FDA has approved Xembify® (immune globulin subcutaneous, human - klhw), manufactured by Grifols, to treat primary humoral Immunodeficiency (PI) in patients who are at least two years of age. Conditions that can be treated with Xembify include but are not limited to congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
A group of approximately 350 individual rare genetic disorders, PI affects an estimated 250,000 individuals in the United States, according to the Immune Deficiency Foundation. Individuals with PI disorders have a compromised immune system, increasing their risk of infection. Immune globulin replacement therapy introduces antibodies to the bloodstream that help support the immune system in fighting off infectious organisms such as bacteria and viruses. Several human immune globulin products are currently available on the U.S. market, some intended for subcutaneous administration, others for intravenous administration.
Xembify is a 20% human immune globulin product intended for subcutaneous administration. Recommended dosing is based on individual patient factors, such as previous history of treatment with immune globulin products, the patient’s weight, and clinical response. A black box warning cautions that there is a risk of thrombosis (blood clots) associated with the use of human immune globulin products.
Although pricing information is not yet available, Grifols has announced plans to launch Xembify during the last quarter of 2019.