LFB USA is focused on developing and commercializing life-changing and life-saving therapies for patients, particularly in the area of rare diseases. We’re committed to reaching more patients with innovative treatments and making a positive impact across more markets and therapeutic areas.
Understanding the clinical trial and regulatory processes are essential. The company’s deep experience helps product candidates strategically navigate the process. Just one example of this is LFB’s LR769 program. The proprietary recombinant form of human Factor VIIa has been approved by the FDA for treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies) (https://www.fda.gov/news-events/press-announcements/fda-approves-additional-treatment-adults-and-adolescents-hemophilia-or-b-and-inhibitors).
Approximately 15-20% of people with hemophilia will develop an inhibitor to the product used to treat or prevent bleeding episodes, according to the Centers for Disease Control and Prevention (CDC). Developing an inhibitor is one of the most serious and costly complications of hemophilia. For this reason, the LFB product pipeline has a product candidate for treating three separate patient populations in Hemophilia with Inhibitors: the approved treatment in adults and adolescents and the follow-on indications for the pedriatric and surgical patients (both for which the Phase III clinical trials are completed and will be filed soon with the FDA for review/approval).
Unprecedented scalability and cost efficiencies afforded by the company's proprietary rPRO Technology™ will enable the broadest possible product availability for the patients who could benefit from these innovative therapies.