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Grifols announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration for Yimmugo®, an innovative intravenous immunoglobulin therapeutic, to treat primary immunodeficiencies.

Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full commercialization and distribution of the immunoglobulin therapy Yimmugo® in the U.S., following its Biologic License Application approval by the U.S. Food and Drug Administration on June 13, 2024.

Grifols, one of the world’s leading producers of plasma-derived medicines, announced that Biotest, a Grifols Group company, forecasts approximately USD 1 billion in revenue from sales in the United States of its intravenous immunoglobulin Yimmugo® during the next seven years, following recent Food and Drug Administration approval to treat primary immunodeficiencies.

Grifols announced that Biotest’s positive topline results from AdFIrst, its phase 3 clinical trial of its fibrinogen concentrate, BT524, advance this potential treatment for acquired fibrinogen deficiency, an underserved growth market.