UCB has announced hat the FDA has approved 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.
The FDA recently approved a filing for Cimzia in the treatment of adults with active psoriatic arthritis (PsA). 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.
About Cimzia in Europe
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.3 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.