UK launches FibCLOT®▼ LFB’s human fibrinogen concentrate
Written by Daniel Barnes, March 1, 2017
LFB Biopharmaceuticals announced today the UK launch of FibCLOT, its human fibrinogen concentrate. This follows the granting of a UK Marketing Authorisation in April 2016, after a decentralised application to the Regulatory Authorities in Europe, and offers increased therapeutic choices for affected patients.
FibCLOT® is indicated for the treatment and perioperative prophylaxis of bleeding in patients with congenital hypo- or afibrinogenaemia with a tendency to bleed . These are rare bleeding disorders affecting approximately one in a million people . A clinical study in children has also recently been completed, with the largest cohort of paediatric patients ever included in such a trial to date.
The LFB Group is currently increasing its production capacity to make this cutting-edge treatment even more accessible. New industrial units in Lille and a new plant in Arras, both in northern France, will allow LFB to manufacture up to 300 kg of fibrinogen for supply to healthcare professionals within the next ten years.
Congenital fibrinogen deficiency is a rare, potentially life-threatening genetic bleeding disorder affecting approximately one in a million people. As fibrinogen, also known as Factor I (one), is necessary for blood clot formation, reduced, absent or abnormal amounts of fibrinogen affect the body’s ability to form a clot effectively. Symptoms of congenital fibrinogen deficiency include excessive bleeding following an injury, surgery or childbirth, nosebleeds, mouth bleeds, easy bruising, bleeding of the umbilical cord at birth, spontaneous bleeding, joint or mouth bleeds and problems during pregnancy.
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