A Marketing Authorisation Application (MAA) has been submitted to the European authority requesting the approval of Cimzia (certolizumab pegol) as a subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis (RA).
UCB announced yesterday that European authority Medicines Agency (EMEA) has accepted the MAA for review.
Subject to approval, Cimzia will be the first and only PEGylated, Fc-Free anti-TNF (Tumour Necrosis Factor alpha) biologic therapy available in Europe for the treatment of RA.
“Along with a fast onset of action, Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function,” said Olav Hellebo, President of Inflammation Operations for UCB.
“With millions of people suffering from rheumatoid arthritis across the globe, Cimzia, when approved, will provide a new and effective treatment option for this debilitating condition.”
The MAA filing is based on UCB’s clinical programme with data from more than 2,300 patients involved in several multicentre, placebo-controlled phase III trials, totaling over 4,000 patient-years of experience.
This European filing follows the February 2008 Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for Cimzia for the treatment of adult patients with active rheumatoid arthritis (RA). On 22 April 2008, the US Food and Drug Administration (FDA) approved Cimzia for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate to severe active disease who have had inadequate response to conventional therapy.