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Yimmugo approved in Germany for replacement therapy in primary antibody deficiency syndromes and secondary immune deficiency.- Biotest AG

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Published:20th Nov 2022

Biotest AG announced that the German competent authority, the Paul-Ehrlich-Institute, has approved the new intravenous immunoglobulin Yimmugo (IgG Next Generation) in Germany.

 

"Biotest is expanding its immunoglobulin product portfolio with an innovative new product. Yimmug offers patients and physicians another important treatment option whose safety, efficacy and tolerability have been proven in the approval studies," emphasises Dr Jörg Schüttrumpf, Chief Scientific Officer of Biotest AG. "The market launch of Yimmugo in Germany will start before the end of this year."

The approval in Germany was preceded by the recently successfully completed decentralised procedure in Germany and Austria, which Biotest submitted in March 2022. The approval procedure was successfully completed in less than 7 months. Approval in Austria is also imminent. Further approvals in European and non-European countries are planned.

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 for replacement therapy in primary antibody deficiency syndromes and secondary immune deficiency, as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki’s disease. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for highest product quality and an extremely responsible use of resources.

Condition: Primary Immune Deficiency
Type: drug

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