Registration of FibCLOT®, LFB’s human fibrinogen, in Europe
Les Ulis (France), 22 February 2016 – LFB SA announces it has obtained the first three European marketing authorisations for its human fibrinogen, in Germany, Denmark and Hungary, via a decentralised licensing procedure. Thirteen more marketing authorisations are expected in Europe in the coming months.
For patients with a rare bleeding disorder: The human fibrinogen from LFB has been licensed since 22nd January in Germany and Hungary, and 27th January 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
A genuine treatment solution : 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. “Fibrinogen is a medicine that also has strong therapeutic potential in the intensive care field, where it is attracting interest from many clinicians for treating certain types of bleeding. A lot remains to be done in this field, to which LFB is resolutely committed,” adds Guillaume Bologna, Executive Vice-President for Developments within the LFB Group.
LFB is increasing its production capacity to make this cutting-edge treatment even more accessible. New industrial plants on the site in Lille, as well as the dedicated new factory for plasma-derived medicines in Arras, both in the north of France, will allow LFB to manufacture up to 300 kg of fibrinogen for European and international health professionals within the next ten years.
LFB is a key player in rare diseases in Europe: “The FibCLOT® licences in Europe are a testament to the vitality of LFB’s research and development, as they come just a few months after the first European marketing authorisations for our 10% liquid immunoglobulin, IQYMUNE®, indicated in rare immune system disorders,” states Christian Béchon, CEO of the LFB Group.
After Denmark, Hungary and Germany, FibCLOT® is due to be licensed in the following European countries: Austria, Belgium, Czech Republic, Finland, Greece, Italy, Luxembourg, the Netherlands, Norway, Slovenia, Slovakia, Spain and the United Kingdom. There are also plans to license LFB’s fibrinogen in a number of countries around the world.
About the LFB Group: LFB is a biopharmaceutical company that develops, manufactures and markets medicines indicated in the treatment of serious and often rare diseases in some major therapeutic areas: haemostasis, immunology and intensive care. Number one in France and sixth worldwide in the field of plasma-derived medicines, the LFB Group is also one of the top European companies for developing innovative biotech medicines and treatments.
The LFB Group’s growth strategy aims to expand its activities internationally and to develop innovative therapies. Today, the LFB Group markets its products in more than 40 countries around the world and it achieved a turnover of 501.9 million euros in 2014. www.groupe-lfb.com