June 17, 2024

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

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  • 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
  • Launching Yimmugo in the U.S. will over time significantly add to Grifols Group sales and underpins its future growth strategy

Barcelona, Spain, June 17, 2024 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).

Yimmugo, developed by Biotest, adds to Grifols’ strong franchise of industry-leading intravenous and subcutaneous Ig treatments at a time of growing demand for plasma-derived medicines to treat immunodeficiencies, in which a part of the body’s immune system is missing or does not function properly, and other medical conditions.

The first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Dreieich, Germany, which is already approved for production and marketing in Europe.

The launch of Yimmugo in the U.S. 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.

Yimmugo is the first of a threesome of Biotest plasma proteins on the horizon destined for markets including the U.S. The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency – it would be the first FC approved for this indication in the U.S. – and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).

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

The strategic acquisition of Biotest and the integration of its specialized resources has significantly accelerated Grifols innovation, deepened its product pipeline and furthered its industry leadership.

About Yimmugo® (IgG Next Generation)

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.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

See full Prescribing Information for YIMMUGO.

  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3)
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4)

For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (2.1, 2.3, 5.3)