FibCLOT®, Human Fibrinogen from LFB, Obtains First Marketing Authorisations in Europe
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:
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:
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
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
Sandrine Charrières, Tel.: +33 (0)1 69 82 72 80
Corporate Communications Director
Jeanne Bariller, Tel.: +33 (0)6 15 51 49 40
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