The European Commission has granted approval for UCB’s Cimzia, in combination with MTX, for the treatment of moderate to severe active rheumatoid arthritis (RA).
The treatment has been granted approval for use in adult patients who have shown an inadequate response to disease-modifying antirheumatic drugs (DMARDs) including MTX.
Cimizia can also be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
UCB chief medical officer Dr Iris Loew-Friedrich said that Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function.
“These are key areas of concern for rheumatologists when treating patients with active RA, and we therefore believe Cimzia provides an important new treatment option,” Loew-Friedrich said.
EU approval was based on the results of the RAPID 1 and RAPID 2 clinical trials, which achieved statistically significant responses compared to placebo.
Additionally, the RAPID 1 study showed that patients receiving Cimzia in combination with MTX saw sustained treatment levels for as long as two years.
Cimzia has already been approved in the US for the treatment of RA and Crohn’s disease.