This article is more than 5 years old. Information may no longer be current.
UCB announces regulatory filings for Cimzia for treating psoriatic arthritis, axial spondylarthritis
Click Here to Manage Email Alerts
Two regulatory filings with the FDA and European Medicines Agency to extend the marketing authorization of Cimzia for treatment of adults with psoriatic arthritis or axial spondylarthritis were announced today by the drug’s manufacturer.
Cimzia (certolizumab pegol, UCB), an Fc-free, pegylated, anti-tumor necrosis factor (anti-TNF), is approved in the United States for treatment of adults with moderately to severely active rheumatoid arthritis (RA), and for reducing symptoms of Crohn’s disease and maintaining clinical response for those who have responded inadequately to conventional therapy, according to a news release from UCB.
In the European Union, certolizumab pegol is approved in combination with methotrexate (MTX) for treating moderate to severe active RA in adults unresponsive to disease-modifying antirheumatic drugs, including MTX.
“We are committed to providing treatments for patients with severe diseases such as [psoriatic arthritis] and [axial spondylarthritis],” Iris Loew-Friedrich, MD, PhD, chief medical officer and executive vice president, UCB, said in the release.
Two phase 3 multicenter, randomized, double blind, placebo-controlled studies were designed to evaluate the safety and efficacy of certolizumab for patients with psoriatic arthritis [PsA] and axial spondylarthritis [axSpA].
“The clinical study supporting the axSpA filing represents the first phase 3 study with anti-TNF to include axSpA patients with and without definitive radiographic evidence of structural damage to the spine,” Loew-Friedrich said. “Similarly, the study supporting the PsA filing was the first randomized, controlled study of an anti-TNF in PsA to include patients with and without prior anti-TNF exposure.”
In the axSpA study, 325 patients with the condition received certolizumab pegol 400 mg at baseline and weeks 2 and 4, then were randomly assigned to receive certolizumab pegol 200 mg every 2 weeks, every 4 weeks or placebo. ASAS20 response at week 12 was the primary endpoint.
In the other study, 409 patients with adult-onset active and progressive PsA received certolizumab pegol 400 mg at baseline, weeks 2 and 4, and then were randomly assigned to receive certolizumab pegol 200 mg every 2 weeks, 400 mg every 4 weeks or placebo. ACR20 response at week 12 was a clinical primary endpoint.