Products under development
- Development of a new dosage and route of administration,
- Development activities seeking approval in the United States.
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.
Recombinant activated factor VII in certain forms of haemophilia:
- Application in progress for approval in Europe,
- Clinical development program in the United States seeking label extensions,
- Regulatory applications in Mexico, Colombia, Algeria and Saudi-Arabia.
The 6 April 2020, the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for the recombinant coagulation Factor VIIa, for the treatment of haemophilia.
- Ongoing clinical development activities seeking label extension in Europe,
- Ongoing activities seeking regulatory submission in the United States.
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.
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 of the products under development, please refer to the following websites:
- International Clinical Trial Registry Platform : http://apps.who.int/trialsearch/
- In United States: https://clinicaltrials.gov/
- In Europe: clinicaltrialsregister.eu/