UCB's Cimzia® filed with EMEA for treatment of rheumatoid arthritis
The European marketing authorisation application for Cimzia® has been filed. Subject to approval, Cimzia® will be the first and only PEGylated, Fc-Free anti-TNF (Tumour Necrosis Factor alpha) biologic therapy.
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<0.001). Patients in the RAPID 1 trial also experienced fast and clinically significant improvement in physical function, pain and fatigue from Week 1 and for up to one year (p<0.001).
A pooled analysis of the safety data from the two RAPID studies showed there was a low incidence of injection site pain (n=<3 new cases/ 100 patient-years) and low level of discontinuations due to adverse events (AEs). The most commonly occurring AEs were headache, nasopharyngitis, and upper respiratory tract infections. Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the anti-TNF class.
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 April 22, 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. Cimzia® has been available to doctors and patients in the US since April 24, 2008.
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