Biotest Submits Fibrinogen Application to FDA

Biotest AG has reached a significant milestone by submitting a Biologics License Application for its Fibrinogen to the US Food and Drug Administration (FDA). This product aims to address the unmet medical need for treating acquired fibrinogen deficiency. The application also extends to the treatment and prevention of acute bleeding in patients with congenital fibrinogen deficiency. A decision from the FDA is expected by the end of 2025.

This submission follows Biotest's marketing authorization application in Europe in October 2024. Fibrinogen offers advantages over current treatments, such as cryoprecipitate or fresh frozen plasma, by providing high-purity fibrinogen and faster preparation time. Biotest, a member of the Grifols Group, is focused on broadening patient access to this therapy.