Biotest receives FDA approval for plasma protein therapy

The US FDA has approved Biotest's plasma protein therapy, Yimmugo, as announced in a press release on June 17. Biotest, which operates under Grifols, developed Yimmugo as an intravenous immunoglobulin (IVIg) therapy aimed at treating primary antibody deficiency syndromes. This therapy acts as a substitution therapy for individuals whose antibody levels fall significantly below the standard range or whose immunoglobulin function is compromised due to genetic defects affecting B cell development and function.

Yimmugo made its first appearance in Europe in late 2022, following approval from the European Medicines Agency (EMA) for its production and marketing. Biotest manufactures this therapy at its facility in Dreieich, Germany, using a polyvalent immunoglobulin G preparation derived from human blood plasma.

The approval of Yimmugo in the US marks a significant milestone for Biotest. Earlier this year, the company saw an 83.6% increase in first-quarter sales, largely driven by Yimmugo’s performance. The revenue for the first quarter of 2024 amounted to €215.2 million ($230.5 million), with Yimmugo’s sales growing from €7.5 million to €11.1 million.

Peter Janssen, CEO of Biotest, remarked in the June 17 press release, "With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care."

Biotest is also working on other plasma protein therapies. One such therapy is AdFIrst (BT524), a fibrinogen concentrate designed to treat acquired fibrinogen deficiency. AdFIrst has shown positive results in a Phase III study (2017-001163-20), which was reported to be non-inferior to the existing standard of care. Grifols released these findings in February 2024, highlighting the therapy's effectiveness.

Additionally, Biotest is developing trimodulin (BT-588), another plasma protein therapy aimed at treating severe community-acquired pneumonia. This treatment is currently being evaluated in the Phase III ESsCAPE study (NCT05722938).

Biotest's development efforts are part of a larger strategy following its acquisition by Grifols in 2021. The acquisition occurred when Grifols bought Tiancheng Pharmaceutical, which held a majority stake in Biotest. The incorporation of Biotest into Grifols has bolstered the latter's capabilities in plasma protein therapies. Jörg Schüttrumpf, Grifols’ chief scientific innovations officer, noted earlier this year that the company has the in-house capability to manufacture AdFIrst.

The FDA's approval of Yimmugo is a pivotal achievement that not only underscores Biotest's innovative contributions to immunoglobulin therapies but also highlights the company's commitment to addressing unmet medical needs in patients with antibody deficiencies. The broader implications of this approval suggest an enhanced global availability and access to advanced immunoglobulin therapies, potentially transforming patient care standards and outcomes.