Chronic Leukaemia Treatment Granted EU Orphan Status

25 November 2009 (Last Updated November 25th, 2009 18:30)

French biopharmaceutical company LFB has received orphan drug status in Europe for their recombinant anti-CD20 monoclonal antibody as a treatment for chronic lymphocytic leukaemia. Orphan drug status is granted to boost the development of treatments for rare and difficult diseases suc

French biopharmaceutical company LFB has received orphan drug status in Europe for their recombinant anti-CD20 monoclonal antibody as a treatment for chronic lymphocytic leukaemia.

Orphan drug status is granted to boost the development of treatments for rare and difficult diseases such as CLL, which represents 30% of cases of leukaemia in adults in Europe and is generally considered to be untreatable.

LFB's anti-CD20 antibody (LFB-R603) is a chimeric recombinant monoclonal antibody directed towards the CD20 antigen expressed on the surface of B cells.

The specific profile of the antibody has been demonstrated to have exceptional cytotoxicity in non-clinical trials, which suggest LFB-R603 could be more effective than the reference anti-CD20 antibody.

Phase I/II clinical trials for this indication of LFB-R603 are currently underway.