UCB announced today that the U.S. Food and Drug Administration (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.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 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.