Crohn's disease, a chronic and debilitating inflammatory disease of the gastrointestinal tract, affects nearly one million patients worldwide and an estimated 500,000 people in the United States.
UCB, a global biopharmaceutical company, announced on 2nd March 2006 the submission of a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for the approval of CIMZIA (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease. CIMZIA™ would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease when approved. The BLA includes safety and efficacy data from well-controlled clinical trials in more than 1,500 patients with Crohn's disease. The pivotal studies (PRECiSE 1 and PRECiSE 2) that support the BLA submission met their primary endpoints by demonstrating that CIMZIA™ induced clinical response and maintained clinical response and remission in a significant percentage of patients with Crohn's disease.
The CIMZIA™ BLA package represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn's disease treatment.
Currently, there are significant unmet needs among Crohn's patients. Therefore, additional therapeutic agents like CIMZIA™ will increase the doctors’ ability to provide effective long-term relief to patients from this debilitating disease. CIMZIA™ studies are also ongoing in the treatment of rheumatoid arthritis and psoriasis.
Source: [PharmaLive] & [UCB Press Release]
Comment Preview