UCB has announced positive top-line results for signs and symptoms from two new phase III studies for Cimzia (certolizumab pegol), the first Fab' fragment anti-TNF (Tumour Necrosis Factor), in the treatment of rheumatoid arthritis.
In both the Rapid 1 (027) and Rapid 2 (050) studies Cimzia in combination with methotrexate, demonstrated superiority to placebo, and a statistically significant improvement in the signs and symptoms of rheumatoid arthritis as measured by all American College of Rheumatology (ACR) scores: ACR20, 50, and 70.
UCB also provided an update on the status of the US approval of Cimzia in the treatment of Crohn's disease. UCB has received a Complete Response Letter from the United States Food and Drug Administration (FDA) requesting additional information and clarification on data submitted in its Biologics License Application (BLA) for the approval of Cimzia in Crohn's disease.
"We have absolute confidence in both the efficacy and tolerability profile of Cimzia and in gaining US approval" said Melanie Lee, executive vice president R&D for UCB. "We are extremely pleased by the rheumatoid arthritis results and will work closely with the FDA to clarify any questions that they have, or may have, regarding Cimzia for the treatment of Crohn's disease and rheumatoid arthritis."