FDA Approves Yimmugo to Treat Primary Immunodeficiencies
Grifols announced that Biotest has received approval from the U.S. Food and Drug Administration (FDA) for Yimmugo, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).
- Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood
plasma to treat immunodeficiencies, in which a part of the body’s immune system is missing or
does not function properly, and other medical conditions. - The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary
- antibody deficiency syndromes.
- As the first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Germany.
