The European submission follows the filing of a biologics license application (BLA) for Cimzia (certolizumab pegol, CDP870) to the FDA on March 1, 2006 and is based on safety and efficacy data from over 1,500 patients with Crohn’s disease.
The two pivotal phase III studies that support the MAA submission (PRECiSE 1 and PRECiSE 2) met their primary endpoints with statistical significance, demonstrating Cimzia’s sustained and consistent efficacy in patients with Crohn’s disease.
The Cimzia marketing authorization application (MAA) submission represents the largest biologic clinical trial database submitted to the European Medicines Agency (EMEA) for Crohn’s disease treatment. The PRECiSE studies also represent the broadest clinical trial program, in terms of patient type, in Crohn’s disease, encompassing patients with previous exposure to an anti- TNF treatment with a range of concomitant therapies and variable duration of disease.
If approved, Cimzia would represent the first and only biologic administered by monthly subcutaneous injection as a treatment for Crohn’s disease patients.
In addition to the current development program in Crohn’s disease, ongoing studies are investigating the efficacy and tolerability of Cimzia in the treatment of rheumatoid arthritis and psoriasis.