US FDA agrees to review UCB's BLA for Cimzia

UCB said the US Food and Drug Administration (FDA) has agreed to accept, for filing and review, a biologics license application (BLA) for Cimzia (certolizumab pegol) for the treatment of adult patients with active rheumatoid arthritis (RA). Cimzia is an investigational agent. If approved, Cimzia will be the first and only PEGylated anti-TNF (Tumour Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis.

"As a new anti-TNF, we believe that Cimzia would provide an important new option for people living with this disease," said Olav Hellebo, president Inflammation Operations, UCB.

The BLA is based on data from more than 2,367 patients and includes three multi-centre, placebo-controlled phase III trials which were recently presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.

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.Preparation for submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Cimzia in the treatment of RA is ongoing, with filing planned in the first half of 2008, the company informed. In September 2007, Cimzia was approved in Switzerland for the treatment of Crohn's disease and it was launched in January 2008.