Biotest AG announced that the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) has been accepted for review by the U.S. Food and Drug Administration (FDA) after the 60-day validation phase. With this filing notification the marketing authorization application will enter the next phase, in which the application dossier will be subjected to an in-depth substantive review. The marketing authorization application covers the indication primary immunodeficiencies (PID).

After receiving approval, Biotest plans to expand the indication to include chronic primary immune thrombocytopenia (ITP). The FDA's decision on the marketing authorization application of Yimmugo is expected on June 29, 2024. Biotest's new immunoglobulin is manufactured in an innovative production process and is the main product of the new Biotest Next Level production facility.

The new production facility, which uses technologies, represents Biotest's increased commitment to the global immunoglobulin market.