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FDA approves Cimzia for treating adults with ankylosing spondylitis

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The FDA has approved certolizumab pegol for treating adults with active ankylosing spondylitis, the drug’s manufacturer, UCB, announced today.

The approval of certolizumab pegol (Cimzia) was based on results of a phase 3, multi-center, double-blind study of patients with active axial spondylarthritis (axSpA), with the majority having ankylosing spondylitis (AS), according to a press release. A complete response letter also was issued by the FDA for a supplemental biologics license application for certolizumab pegol for active axSpA, UCB announced.

Researchers randomized 325 patients with active axSpA, including 178 patients with AS, to receive treatment of certolizumab pegol 200 mg every 2 weeks, 400 mg every 4 weeks or placebo. A loading dose of certolizumab pegol or placebo was given to all patients at weeks 0, 2 and 4.

For all patients, both dosing cohorts displayed clinical and statistical significance for the primary efficacy variable, the proportion of patients achieving an ASAS20 response rate at week 12, when compared with the placebo cohort. A greater portion of patients with AS who were in the 200 mg or 400 mg treatment groups met ASAS20 response at week 12 when compared with AS patients treated with placebo, with similar responses between the two Cimzia dosing groups.

Adverse events were reported for 70.4% of patients treated with certolizumab pegol compared with 62.6% of patients treated with placebo. Serious adverse events occurred in 4.7% of patients, regardless of treatment. Reported serious infections related to Cimzia treatment include active tuberculosis, invasive fungal infections, bacterial, viral and other infections, and malignancies, according to the press release.

A filing for certolizumab pegol to treat adults with active psoriatic arthritis was recently approved by the FDA, according to UCB. It also is approved in the United States for treating adults with moderately to severely active rheumatoid arthritis and for treating symptoms of Crohn’s disease.

“Cimzia provides an important new treatment option for people living with active AS and for rheumatologists,” Iris Loew-Friedrich, MD, PhD, chief medical officer and executive vice president, UCB, said in the release. “FDA approval of Cimzia for active AS is an important milestone for UCB.”