LFB’s fibrinogen and 10% immunoglobulin authorized for use in Europe
Two plasma-derived medicinal products developed by the LFB Group have successfully passed decentralized authorisation procedures in Europe. The LFB Group’s fibrinogen is now authorised for use in sixteen European countries, while its 10% immunoglobulin is now authorised for use in fifteen countries.
Both medicinal products are authorised in the following countries: Austria, Belgium, the Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Italy, Luxembourg, the Netherlands, Slovakia, Spain, Sweden and the United Kingdom. Fibrinogen is also authorised in Norway.
The LFB Group’s fibrinogen is indicated for the perioperative management of patients with rare genetic coagulopathy; there are several hundred of these patients in Europe. It is one of the rare fibrinogen products approved in Europe for this indication.
LFB Group’s 10% immunoglobulin is approved, as other immunoglobulins, for immune system disorders. These diseases affect tens of thousands of people in Europe and, most often, involve chronic disease management. The LFB Group’s 10% immunoglobulin is currently in Phase III clinical development trials in Europe for two indications in the field of neurology.
Due to a significant increase in the demand for fibrinogen and immunoglobulins worldwide, these two medicinal products will be directly affected by the LFB Group’s plans to triple its production capacity within ten years, an ambition facilitated by the new plant under construction in Arras (France). .