Biotest’s Yimmugo receives FDA approval to treat primary immunodeficiencies

Published: 18-Jun-2024

The immunoglobulin therapeutic has now been approved for treating primary immunodeficiencies in the US, following its acceptance into the European market

Biotest, a Grifols Group company focusing on developing plasma-derived medicines, has received approval from the US Food and Drug Administration (FDA) for Yimmugo.

Yimmugo is a novel intravenous immunoglobulin (Ig) therapeutic which will be used to treat primary immunodeficiencies. (PID)

Expanding Yimmugo’s global footprint

The first US-approved medicine in Biotest’s portfolio, Yimmugo is produced at its production facility in Dreieich, Germany — which is already approved for production and marketing in Europe.

The launch of Yimmugo in the US in the second part of 2024 follows its successful introduction in Europe at the end of 2022, and is poised to add to Grifols' future revenue growth and profitability.

Ig’s for a range of disease areas

Yimmugo is the first of a threesome of Biotest plasma proteins on the horizon destined for global markets — including the US. 

The other two candidates, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency and a polyvalent Ig to treat community-acquired pneumonia, or its severe iteration.

“The addition of Biotest’s Yimmugo to our portfolio of intravenous and subcutaneous Igs provides another treatment option for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives,” said the President of the Grifols Biopharma Business Unit, Roland Wanderer.

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