The US Food and Drug Administration (FDA) has approved UCB's Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia for the treatment of adults with active axial spondyloarthritis (axSpA). UCB is working with the FDA to determine a path forward to bring Cimzia to US patients living with active axSpA.

With these four indications, UCB confirms expected global peak sales for Cimzia of at least €1.5 billion during the second half of the decade.

The approval of Cimzia for adults with active AS was based on a phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patients with active axSpA, in which the majority had AS.

“AS is a lifelong disease that can cause pain and stiffness and at times can be very debilitating for people living with it. Cimzia provides an important new treatment option for people living with active AS and for rheumatologists. FDA approval of Cimzia for active AS is an important milestone for UCB and bolsters Cimzia’s broad rheumatology portfolio of approved indications in the US,” said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB.

In the efficacy and safety study of Cimzia, patients with active axSpA, including AS, were randomized (1:1:1) to receive Cimzia 200 mg every two weeks, 400 mg every four weeks or placebo. There were a total of 325 patients in the study, of which 178 had AS. All patients received a loading dose with Cimzia or placebo at weeks 0, 2 and 4. The primary efficacy variable, the proportion of patients achieving an ASAS20 response rate at week 12, was met with clinical and statistical significance in both dosing arms versus placebo.

A greater proportion of AS patients treated with Cimzia 200 mg every two weeks or 400 mg every four weeks achieved ASAS20 response at week 12, compared with AS patients treated with placebo. Responses were similar in patients receiving Cimzia 200 mg every two weeks and 400 mg every four weeks.

In this study, adverse events occurred in 70.4% of patients in the Cimzia group (combined dose) compared to 62.6% of patients in the placebo group. Serious adverse events occurred in 4.7% of patients in both the Cimzia group (combined dose) and in the placebo group.2 The safety profile for patients with AS treated with Cimzia was similar to the safety profile seen in patients with RA and in patients with previous experience with Cimzia. Please see important safety information at the end of this press release for additional details about adverse events associated with Cimzia.

The FDA recently approved a filing for Cimzia in the treatment of adults with active psoriatic arthritis (PsA). In the US, 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.

In the EU, Cimzia in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

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 of the CHMP opinion. The European Medicines Agency is currently reviewing a filing for certolizumab pegol in the treatment of adult patients with active PsA.

axSpA is an inflammatory rheumatic disease that mostly affects the spine and sacroiliac joints. axSpA can be further divided into ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), depending on the presence or absence of definitive changes on x-ray in the sacroiliac joints (SIJ).

Ankylosing Spondylitis, or AS, is a chronic inflammatory rheumatic disease of the spine and is the most well-recognized subset of axSpA. The symptoms of AS can vary, but most people experience back pain and stiffness due to inflammation which can proceed to fusion of the sacroiliac joints. The condition usually begins between 15 and 35 years of age, with prevalence estimated to be .5% of the US population. AS is more common in men than in women. Ankylosing spondylitis has a genetic component and is associated with the HLA-B27 gene.

UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.