Dec 22 2010
LFB received from the German regulatory authority (Paul-Ehrlich-Institute) a positive review feedback for the closing of the Mutual Recognition Procedure (MRP) of Willfact® 1000 IU with Germany as the reference member state.
Willfact® (pure human von Willebrand factor (vWF) concentrate) was launched in Germany in May 2010 for the prevention and treatment of haemorrhages or surgical bleeding in von Willebrand Disease (vWD) when Desmopressin (DDAVP) treatment alone is ineffective or contra-indicated. It can be used also as long-term prophylaxis in von Willebrand patients when indicated.
LFB BIOMEDICAMENTS got a positive review for Willfact® in the following countries: Spain, United Kingdom, Portugal, Czech Republic, Austria, Poland, Denmark, Slovakia, Norway, Hungary, Sweden, Latvia, Lithuania, Estonia and for Willefact® in Slovenia. Following final local regulatory approvals and pricing, LFB BIOMEDICAMENTS (or its partners) is expecting to begin launching Willfact® in some countries during the second quarter of 2011.
LFB's pure human von Willebrand factor concentrate has been available for von Willebrand patients since 2003 in France and since then in several European countries (Belgium, Germany, Finland, Greece, Italy, Luxembourg and The Netherlands) under the name Wilfactin® or Willfact®.
With this unique product serving specifically the rare disease von Willebrand patient community, LFB is pursuing and reinforcing its growth strategy that seeks to implement and extend its plasma derived products commercialisation within the international countries and particularly in Europe.
LFB BIOMEDICAMENTS