FDA panel recommends Cimzia for treating active axial spondylarthritis, ankylosing spondylitis

The FDA Arthritis Advisory Committee voted in favor of recommending certolizumab pegol for treating adults with active axial spondylarthritis, including patients with ankylosing spondylitis, according to drug manufacturer UCB.

The committee voted 7-6, with one abstention, for the recommendation for certolizumab pegol (Cimzia), according to a press release. The FDA is not bound to the committee’s approval for UCB’s supplemental biologics application for the drug.

The panel also voted (8-5, one abstaining) that the data on certolizumab pegol provided “a clinical meaningful beneficial effect” on treating axial spondylarthritis (axSpA), including ankylosing spondylitis (AS). The panel voted 13-1 that Cimzia’s safety profile was adequate.

“UCB is encouraged by the committee’s recommendation,” Iris Löw-Friedrich, MD, PhD, executive vice president of BioDevelopment and chief medical officer, UCB, said in the release. “Their action represents an important evidence-based, patient-focused step toward addressing the unmet needs of people living with axSpa.”

Certolizumab pegol is approved in the United States for treating adults with moderately to severely active rheumatoid arthritis, for reducing symptoms of Crohn’s disease and maintaining clinical response for patients with inadequate response to conventional therapy, the release said.

UCB announced in February regulatory filings with the FDA and the European Medicines Agency (EMA) to extend the marketing authorization of certolizumab pegol for treating adults with active psoriatic arthritis and for adults with active axSPA. Those filings are under review by the FDA and the EMA, according to the release.

In the European Union, certolizumab pegol is approved in combination with methotrexate (MTX) for treating moderately to severely active RA in adults unresponsive to disease-modifying antirheumatic drugs, including MTX.