The BLA is based on data from more than 2,367 patients and includes three multi-center, placebo-controlled Phase III trials. In these studies Cimzia, given with methotrexate, was shown to be significantly more effective than methotrexate alone for the inhibition of joint damage progression in patients with active rheumatoid arthritis (RA) as early as 24 weeks (RAPID 1 and RAPID 2). Cimzia was shown to rapidly reduce the signs and symptoms of active RA with peak ACR50 and 70 responses achieved at 14 and 16 weeks. Improvement in physical function and quality of life measures were also seen for up to one year (RAPID 1).
Cimzia is an investigational agent which, if approved, will be the first and only PEGylated anti-TNF (Tumor Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis. Preparation for submission of a marketing authorization application to the European Medicines Agency (EMEA) for Cimzia in the treatment of RA is ongoing, with filing planned in the first half of 2008.