Cimzia(R) Filed With EMEA For Treatment Of Rheumatoid Arthritis, Europe

UCB announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of Cimzia® (certolizumab pegol) as a subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis (RA) and has been accepted 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 multi-centre placebo-controlled Phase III trials totaling over 4,000 patient-years of experience. Cimzia® has been studied at two or four week dosing intervals, and administered together with methotrexate (MTX) or as monotherapy.


In the RAPID trials, Cimzia® together with MTX demonstrated a rapid and significant reduction in the signs and symptoms of active RA as early as Week 1 and inhibited progression of structural damage, with results maintained through to week 52 (p