The FDA has accepted UCB’s biologics license application (BLA) for Cimzia, a potential treatment for active rheumatoid arthritis (RA).

The BLA includes data from three multicenter, placebo-controlled Phase III trials. In two of these studies, Cimzia (certolizumab pegol) given in combination with methotrexate was more effective than methotrexate alone for inhibiting the progress of joint damage in patients with active RA.

In the third trial, the drug demonstrated efficacy as a monotherapy in patients who had failed at least one course of disease-modifying anti-rheumatic drug therapy.

If approved, Cimzia will be the first PEGylated antitumor necrosis factor biologic therapy for RA, according to UCB. The company also plans to submit a marketing authorization application for Cimzia to the European Medicines Agency for this indication.