UCB‘s Cimzia has received approval from the FDA for the treatment of adult patients with active psoriatic arthritis (PsA). A Phase III study showed that Cimzia rapidly improved the signs and symptoms of PsA for patients with response observed as early as the first week of treatment for some patients.

In the U.S., Cimzia is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. In addition, it is approved for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. The FDA is also reviewing a filing for Cimzia® in the treatment of adults with active axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS).

FDA’s approval of Cimzia for active PsA is based on data from the RAPID-PsA study, an ongoing, Phase III, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of certolizumab pegol in 409 patients with active and progressive adult onset PsA.

The EMA is currently reviewing a filing for certolizumab pegol in the treatment of adult patients with active PsA. In September 2013, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia in the treatment of adult patients with severe active axSpA. A final decision from the European Commission is expected within two months.