UCB has announced 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.
If approved, CIMZIA would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.
"Our BLA submission is an important milestone for UCB; it represents the tremendous efforts of UCB's CIMZIA development team, and marks UCB's entry into the biologics market," said Roch Doliveux, CEO and Chairman of the Executive Committee for UCB. "We plan to request marketing authorization from the European Agency for the Evaluation of Medicinal Products (EMEA) in a matter of weeks. UCB is also continuing its research and development work to explore additional auto-immune diseases for this promising biologic."
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.
"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 William Sandborn, M.D., Professor of Medicine at the Mayo Clinic College of Medicine and a leading investigator in the CIMZIA clinical trial program. "Our experience in the PRECiSE clinical trials program has shown CIMZIA to be a well-tolerated and effective treatment. In addition, subcutaneous administration is a welcomed attribute for patients and can offer greater convenience."
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.