LFB's FibCLOT human fibrinogen gets approvals in Europe

France’s LFB Group (formerly called Laboratoire francais du Fractionnement et des Biotechnologies) has obtained the first three European marketing authorizations for its human fibrinogen, FibCLOT in Germany, Denmark and Hungary, via a decentralized licensing procedure. 13 more marketing authorizations are expected in Europe in the coming months.

For patients with a rare bleeding disorder: The human fibrinogen from LFB has been licensed since January 22 in Germany and Hungary, and January 27 in Denmark, to treat patients with a congenital fibrinogen deficiency who are at risk of complications during surgery because of their rare genetic bleeding disorder. This congenital fibrinogen deficiency affects several hundred patients in Europe, and specific management is needed to prevent and treat perioperative bleeding in these patients.

FibCLOT is one of only a few fibrinogens licensed in Europe for this indication, and so it is a genuine treatment solution in its field. A clinical study in children is finished in the same indication, with the largest cohort of paediatric patients ever included in such a trial to date: there were 16 children, including eight children aged under six years.