Clinical trials

The LFB group is committed to investing in international research and the development of new technologies. Research and licensure are currently ongoing in a number of areas, including the following pipeline projects.

Immunology

LFB’s 10% liquid intravenous immunoglobulin received its first marketing authorisation in Europe, in the United Kingdom in August 2015, and is registered in 15 European countries for rare immune system disorders. It’s 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 alloimmunisation situations, successfully completed its phase IIb study for pregnant women.

Haemostasis

The U.S. Biologics License Application (BLA) for LFB’s recombinant activated Factor VII is currently being reviewed by the FDA. 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.

Intensive Care

LFB’s fibrinogen, commercially available in France since 2009, received its first marketing authorisation in European countries, in January 2016, in Denmark. It is registered in 16 European countries, including the UK, for very rare coagulopathies. This product is considered for other potential market approvals including the United States, for acquired coagulation deficit.

Clinical trials

The LFB group is conducting several clinical trials in order to register its products, in the fields of immunology, haemostasis and intensive care.

For more information on clinical trials, please refer to the following websites:

In addition LFB provides grants for research in associated fields. Details are available on request (click here).