Biotest wins FDA approval for plasma protein therapy

2024-06-17

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Biotest wins FDA approval for plasma protein therapy

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来源: Pharmaceutical Technology

The FDA approved Biotest’s plasma protein therapy as per a 17 June press release. Credit: Biotest.

Biotest, a subsidiary of Grifols Grifols, announced that the US FDA granted approval for its plasma protein therapy Yimmugo earlier today (17 June).

Yimmugo is an intravenous immunoglobulin therapy developed as a substitution therapy for primary antibody deficiency syndromes. The Barcelona, Spain-headquartered company launched the therapy in Europe in late 2022, receiving European Medicines Agency (EMA) approval for production and marketing. Biotest is developing the therapy at a production facility in Dreieich, Germany. The therapy uses a polyvalent immunoglobulin G preparation from human blood plasma for producing intravenous administration (IVIg).

Antibody deficiency syndrome is caused by an immunoglobulin level significantly under the standard range or a failure of immunoglobulin function. The primary form of the condition is developed due to genetic defects that dysregulate B cell development and/or function.

Earlier this year, Biotest announced an 83.6% increase in first-quarter (Q1) sales driven by Yimmugo. The company reported revenues of €215.2m ($230.5m) in Q1 2024, with Yimmugo’s sales jumping from €7.5m to €11.1m.

In a 17 June press release, Peter Janssen, Biotest’s CEO, said: “With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care.”

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Alongside Yimmugo, Biotest has been developing two other plasma proteins. One of these is a fibrinogen concentrate therapy, AdFIrst (BT524), for the treatment of acquired fibrinogen deficiency. In 2021, Biotest came under Grifols Grifols via the acquisition of Tiancheng Pharmaceutical, which owned a majority of the shares in Biotest. Earlier this year, Grifols’ chief scientific innovations officer, Jörg Schüttrumpf, said the company has the capability to manufacture Adfirst in-house.

Grifols Grifols released a positive readout from a Phase III AdFIrst study (2017-001163-20) in February 2024, demonstrating that the therapy was non-inferior to the standard of care. Biotest is also developing trimodulin (BT-588), a plasma protein treatment for severe community-acquired pneumonia. The pharma company is currently investigating the therapy in the Phase III ESsCAPE study (NCT05722938).

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