Grifols’ Biotest wins first regulatory approval for its fibrinogen concentrate
Spanish drugmaker Grifols (MCE: GRF) today announced that its fibrinogen concentrate has been approved by the German competent authority, the Paul-Ehrlich-Institut, for the treatment of congenital (CFD) and acquired fibrinogen deficiency (AFD), a rare bleeding disorder.
Germany is the first European country to grant marketing authorization for the company’s fibrinogen concentrate, following a decentralized regulatory procedure with Austria and Spain expected to follow in 2026.
The new fibrinogen concentrate, developed and produced by Biotest (a Grifols Group company), has been approved to treat CFD and AFD caused by bleeding due to surgery or trauma for adults, children and adolescents (0-18 years). CFD is a rare inherited condition present from birth and caused by genetic mutations affecting the production or function of fibrinogen, while AFD typically results from severe bleeding during complex surgical procedures or trauma.
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