Certolizumab pegol
Encyclopedia
Certolizumab pegol is a therapeutic monoclonal antibody produced by UCB
for the treatment of Crohn's disease
and rheumatoid arthritis
.
monoclonal antibody.
in moderate to severe active Crohn's disease. In addition, data from both trials suggest it is well-tolerated. As yet its efficacy has not been directly compared to other anti-TNF-α agents.
Preliminary results of the RAPID 1 and 2 phase III studies were also reportedly positive.
On June 26, 2009, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency
(EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorisation for Cimzia for the treatment of rheumatoid arthritis only - the CHMP refused approval for the treatment of Crohn's disease. The marketing authorisation was granted to UCB Pharma SA on October 1, 2009.
UCB (company)
UCB is a multinational biopharmaceutical manufacturing company headquartered in Brussels, Belgium.- History :UCB was founded on 18 January 1928 by Emmanuel Janssen, a Belgian businessman...
for the treatment of Crohn's disease
Crohn's disease
Crohn's disease, also known as regional enteritis, is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms...
and rheumatoid arthritis
Rheumatoid arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. The process produces an inflammatory response of the synovium secondary to hyperplasia of synovial cells, excess synovial fluid, and the development...
.
Method of action
Certolizumab pegol is a monoclonal antibody directed against tumor necrosis factor alpha. More precisely, it is a PEGylated Fab' fragment of a humanized TNF inhibitorTNF inhibitor
Tumor necrosis factor promotes the inflammatory response, which in turn causes many of the clinical problems associated with autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, hidradenitis suppurativa and refractory asthma. These disorders are...
monoclonal antibody.
Clinical trials
Positive results have been demonstrated in two phase III trials (PRECiSE 1 and 2) of certolizumab pegol versus placeboPlacebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
in moderate to severe active Crohn's disease. In addition, data from both trials suggest it is well-tolerated. As yet its efficacy has not been directly compared to other anti-TNF-α agents.
Preliminary results of the RAPID 1 and 2 phase III studies were also reportedly positive.
Legal status
On April 22, 2008, the U.S. Food and Drug Administration (FDA) approved Cimzia for use in the United States for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.On June 26, 2009, the Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use , formerly known as Committee for Proprietary Medicinal Products , is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.E.g.: In June 2007 the CHMP...
(CHMP) of the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorisation for Cimzia for the treatment of rheumatoid arthritis only - the CHMP refused approval for the treatment of Crohn's disease. The marketing authorisation was granted to UCB Pharma SA on October 1, 2009.