FDA approves Biotest’s plasma-derived treatment for immunodeficiencies

Yimmugo, an intravenous immunoglobulin therapeutic, is the first therapy developed by Biotest to be approved in the US. The treatment has previously been approved in the UK, Germany, and Austria. Following FDA approval, Biotest is planning the commercial launch of Yimmugo in the US market in the second half of 2024. The therapy will be produced at Biotest’s FDA-certified state-of-the-art production facilities in Germany.

Primary antibody deficiency syndromes are a group of immunodeficiencies that comprises over 450 different conditions. Patients with PID have an immune system that is unable to produce effective immunoglobulin antibodies that can defend the body against infections.

Immunoglobulin replacement therapy for PID

Yimmugo is an immunoglobulin replacement therapy designed to provide PID patients with functional antibodies that are able to fight off infections. The intravenous treatment consists of a polyvalent immunoglobulin G preparation obtained from human blood plasma.

Since its acquisition in 2021, Biotest is a company of the Grifols Group. With headquarters in Barcelona, Spain, Grifols is one of the world’s leading producers of plasma-derived and transfusion medicines to treat immunodeficiencies.

“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.

Yimmugo is the first of a group of three plasma-derived medicines that Biotest plans to launch in the US. The other two are currently in late stages of clinical development. One of them is a fibrinogen concentrate to treat acquired fibrinogen deficiency, which would make it the first FC ever approved for this condition in the US. The other is a polyvalent immunoglobulin to treat community-acquired pneumonia.