UCB’s biologics license application (BLA) for Cimzia® (certolizumab pegol) for the treatment of adult patients with active rheumatoid arthritis (RA) has recently been accepted for filing and review by the US FDA.
Cimzia® is an investigational agent. If approved, Cimzia® will be the first and only PEGylated anti-TNF (Tumor Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis.
Cimzia® showed promise in various Phase II trials whose results were presented at the recent American College of Rheumatology (ACR) Annual Scientific Meeting.
Such clinical data were the basis of the BLA submitted to the FDA.
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 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).
Further, Cimzia® administered as monotherapy showed significant improvement in signs and symptoms of RA from week 1 and this benefit was maintained through week 24 (Study 011). The most commonly occurring adverse reactions, were headache, nasopharyngitis, and upper respiratory tract infections.
Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the anti-TNF class.
Cimzia® however, is not new to the market. In September 2007, Cimzia® was approved in Switzerland for the treatment of Crohn’s disease.
Now, on top of the BLA submitted to the FDA for the treatment of adult patients with active rheumatoid arthritis (RA), UCB also has an ongoing preparation for the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Cimzia® in the treatment of RA.
Source: UCB PR