Biotest wins FDA approval for plasma protein therapy
The US Food and Drug Administration (FDA) approved Biotest’s Yimmugo for the treatment of primary antibody deficiencies. Biotest, a subsidiary of Grifols, announced that the US FDA granted approval for its plasma protein therapy Yimmugo.
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.
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 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 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).
June 19, 2024
