UCB ‘confident’ in Cimzia

UCB has announced the results of two phase III clinical trials of Ximzia (certolizumab pegol), a Fab’ fragment anti-tumour necrosis factor for the treatment of rheumatoid arthritis.

The Rapid 1 (027) and Rapid 2 (050) trials showed that administration of Cimzia in conjunction with methotrexate resulted in an improvement in the symptoms of rheumatoid arthritis when measured against American College of Rheumatology scores.

UCB commented that further details of the trial would be published in the new year, including information relating to the prevention of structural damage in patients.

It added that the company had received a letter from the Food and Drug Administration in the US asking for further information and clarification in its application for the approval Cimzia as a treatment for Crohn’s disease.

Melanie Lee, executive vice president of research and development for UCB, said: “We have absolute confidence in both the efficacy and tolerability profile of Cimzia.”

She added that the company was “pleased” with the results of the Rapid trials regarding the treatment of rheumatoid arthritis and would work closely with the regulatory authorities to elucidate any further queries regarding the compound.

In May, UCB announced the results of a phase III clinical trial reporting a clinical response in patients with Crohn’s disease treated with Cimzia.