FDA grants marketing authorisation for Grifols’ intravenous immunoglobulin therapy Yimmugo

grifols investigacion

Renta 4 | The FDA has approved the marketing of Yimmugo, an intravenous immunoglobulin (Ig) therapy developed by Biotest, a company controlled by Grifols, for the treatment of primary immunodeficiencies.

The announcement marks the first approval of a product from Biotest’s portfolio by the US FDA and strengthens Grifols’ intravenous and subcutaneous immunoglobulin franchise in the world’s leading market.

The product, which has already been marketed in the EU since 2022, will be produced for the US market at Biotest’s new FDA-certified plant in Germany and is expected to be launched in the US towards the end of this year.

Assessment: Positive news for Grifols, which thus strengthens its immunoglobulin franchise in the world’s leading market with a product which, together with Fibrinegene and Trimodulin, was the reason behind Grifols’ acquisition of Biotest.

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