If approved, Cimzia (certolizumab pegol, CDP870) would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn’s disease. It is the first and only PEGylated Fab’ fragment of a humanized anti-TNF alpha antibody.
The application includes safety and efficacy data from well-controlled clinical trials in more than 1,500 patients with Crohn’s disease. The pivotal studies met their primary endpoints by demonstrating that Cimzia induced and maintained a clinical response in a significant percentage of patients.
UCB says the Cimzia license application represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn’s disease treatment.
“There are significant unmet needs among Crohn’s patients, so additional therapeutic agents will increase our ability to provide effective long-term relief from this debilitating disease,” commented Dr William Sandborn, professor of medicine at the Mayo Clinic College of Medicine and a leading investigator in the Cimzia clinical trial program.
In addition to the completed and ongoing studies in Crohn’s disease, Cimzia studies are also ongoing in the treatment of rheumatoid arthritis and psoriasis. The company also plans to market the product in Europe.