UCB has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for the approval of Cimzia (certolizumab pegol, CDP870) in the treatment of patients with Crohn's disease. When approved, Cimzia will represent the first and only biologic administered by monthly subcutaneous injection as a treatment for Crohn's disease patients.
The European submission follows the filing of a Biologics License Application (BLA) for Cimzia to the United States Food and Drug Administration (FDA) on March 1, 2006.
"As a leading European biopharmaceutical company, today's submission to the EMEA is an important milestone for UCB, and underscores our commitment to providing a highly effective therapy for patients living with the burden of Crohn's disease," said Olav Hellebo, President of Inflammation Operations for UCB. "With the European MAA filing following closely behind our recent BLA filing to the FDA, the Cimzia development programme is firmly on course. We also continue to explore other indications in the inflammation area for this promising biologic," Hellebo added.
According to the company release, the European submission is based on safety and efficacy data from over 1,500 patients with Crohn's disease. The two pivotal phase III studies (PRECiSE 1 and PRECiSE 2) that support the MAA submission met their primary endpoints with statistical significance, demonstrating Cimzia's sustained and consistent efficacy in patients with Crohn's disease. The Cimzia MAA submission represents the largest biologic clinical trial database submitted to the EMEA for Crohn's disease treatment. The PRECiSE studies also represent the broadest clinical trial programme, 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.
"The results we have seen in the PRECiSE studies have been highly encouraging, suggesting Cimzia to be well-tolerated and effective in the treatment and maintenance of response and remission in patients with Crohn's disease," commented Professor Stefan Schreiber, Professor of Medicine and Gastroenterology at the Christian-Albrechts University, Kiel, Germany, and a leading investigator in the Cimzia clinical trials program. "In addition, Cimzia when approved will offer the convenience of monthly dosing, combined with a patient-friendly subcutaneous route of administration," he added.