Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies

With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand.

Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest’s portfolio and is manufactured with an innovative process at Biotest’s new FDA-certified ‘Next Level’ facility.

U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin

Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources.

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