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CIMZIA(R) (certolizumab pegol), Significantly Reduces Structural Damage and Rheumatoid Arthritis Signs & Symptoms for Up to One Year
Date:11/7/2007

he pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.

UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIA in the treatment of Crohn's disease on February 28, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. CIMZIA was approved in Switzerland for the treatment of Crohn's disease in September 2007. Preparation for a regulatory submission for CIMZIA in the treatment of RA is ongoing, with filing planned by the end of 2007.

References

(1) American College of Rheumatology Subcommittee on Rheumatoid Arthritis

Guidelines. Guidelines for the Management of Rheumatoid Arthritis 2002

update. Arthritis & Rheumatism, 2002 Vol. 46, No. 2

(2) Sharp JT, Lidsky MD, Collins LC, Moreland J. Methods of scoring the

progression of radiologic changes in rheumatoid arthritis: Correlation

of radiographic, clinical and laboratory abnormalities. Arthritis &

Rheumatism, 1971, Vol. 14, No. 6

(3) Stakeholder Insight: Rheumatoid Arthritis, Biologics battle up the

treatment algorithm, Data Monitor, 7 September 2006

(4) Woolf AD & Pfleger B, Burden of major musculoskeletal conditions:

Bulletin of the World Health Organization 2003, 81 (9)

(5) Panayi G What is RA? National Rheumatoid Arthritis Society, June 2006

(6) Hellier, J et al, HLA-DRB1 genes and patients with late onset

rheumatoid arthritis, Annals of Rheumatic Disease, 2001;60:531-533

(7) Firestein G, Rheumatoid Arthritis, ACP Medicine WebMD Publishing,

August 2004

About UCB

UCB, Brussels, Belgium

SOURCE UCB
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