UCB (BRUSSELS, BELGIUM) announced that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency and accepted for review for approval of Cimzia^® (certolizumab pegol) as a subcutaneous treatment for adults with moderate-to-severe active rheumatoid arthritis (RA). Subject to approval, Cimzia will be the first and only PEGylated, Fc-free, anti-TNF (tumor necrosis factor)α biologic therapy available in Europe for the treatment of RA.

The MAA filing is based on UCB’s clinical program with data from >2300 patients involved in several multicenter, placebo-controlled, phase III trials of >4000 patient-years’ experience. The drug has been studied at 2- or 4-week dosing intervals and administered with methotrexate (MTX) or as monotherapy.

In the RAPID trials, Cimzia plus 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 <.001). In addition, patients in the RAPID 1 trial experienced fast and clinically significant improvement in physical function, pain, and fatigue from week 1 and for up to 1 year (P <.001).

A pooled analysis of the safety data from the two RAPID studies showed there was a low incidence of injection site pain (≤3 new cases/100 patient-years) and low level of discontinuations due to adverse events (AEs). Reported serious AEs were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the anti-TNF class.

The European filing follows the February 2008 Biologics License Application with the FDA for Cimzia for to treat adult patients with active RA. On 22 April 2008, the FDA approved the drug for reducing signs and symptoms of Crohn’s disease and for maintaining clinical response in adult patients with moderate-to-severe active disease who have had inadequate response to conventional therapy. The drug has been available in the US since April 24, 2008.

Cimzia has a high affinity for human TNFα, selectively neutralizing the pathophysiological effects of TNFα. UCB also is developing the drug for other autoimmune disease indications.