UCB has announced plans to apply for regulatory approval to market Cimzia® (certolizumab pegol) to treat active psoriatic arthritis by the end of the year.
The plan follows positive, top-line results from the RAPID-PsA Phase III study, which monitored response to certolizumab pegol in patients with adult onset active psoriatic arthritis.
By week 12 of the 48-week, multicentre, double-blind, Phase III study, significant, clinically relevant improvements were already seen in psoriatic arthritis signs and symptoms.
At this time, no new safety concerns were observed and adverse effects mirrored those noted in previous certolizumab pegol trials.
Cimzia is currently approved in the EU in combination with methotrexate for treatment of moderate to severe rheumatoid arthritis (RA) in adults inadequately response to disease-modifying antirheumatic drugs (DMARDs).
In the US, the drug is approved for reducing Crohn’s disease signs and symptoms; maintaining clinical response in adult Crohn’s disease patients with moderate to severely active disease who have had an inadequate response to usual therapy; and for treatment of adults with moderate-to-severely active RA.
Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB, said: “We are pleased that Cimzia has the potential to also benefit patients living with psoriatic arthritis and we are currently preparing for submissions to the regulatory authorities later this year.
“We shall discuss the study results with regulatory authorities and present them at upcoming major rheumatology congresses.”