Products under development
LFB’s 10% liquid intravenous immunoglobulin received its first marketing authorization in Europe, in United Kingdom in September 2015, and is registered in 15 European countries for rare immune system disorders. Its registration is also pending in several other countries around the world, including the United States. In the field of neurology, phase III studies are completed in Europe
The recombinant “anti-D” monoclonal antibody, developed by LFB, for the prevention of certain alloimmunization situations, completed with success its phase IIb study for pregnant woman.
The U.S. Biologics License Application (BLA) for LFB’s recombinant activated Factor VII is currently being reviewed by the FDA, for the treatment of haemophilia. Labelling extensions as well as registrations in other countries are planned.
The von Willebrand factor, already marketed in several countries, is going to be developed for new indications.
LFB’s fibrinogen has been commercially available in France since 2009, received its first marketing authorization in Europe, in January 2016, in Denmark. It is registered in 16 European countries for very rare coagulopathies. This product is considered for other potential market approvals including the United States, for acquired coagulation deficit.
For more information on clinical trials of the products under development, please refer to the following websites: