UCB’s Cimzia granted additional indication by US FDA

Belgian drugmaker UCB (Euronext Brussels: UCB) revealed today that the US Food and Drug Administration has approved its currently marketed drug Cimzia (certolizumab pegol) for the additional treatment of adult patients with active psoriatic arthritis (PsA). In its current indications, Cimzia generated sales of 467 million euros ($632.4 million) in 2012, a year-on-year increase of 50%.

"The FDA's approval of Cimzia for the treatment of active PsA provides an additional, effective treatment option for those living with the condition. Psoriatic arthritis brings with it a heavy disease burden that often strikes during the prime years of life, impacting health-related quality of life and physical function," said Philip Mease, Director Rheumatology Research, Swedish Medical Center and Clinical Professor, University of Washington School of Medicine, Seattle, USA, quoted by UCB. "The RAPID PsA study supporting the US approval is the first randomized, controlled study of an anti-TNF in PsA to include patients with and without prior anti-TNF exposure. The ACR20 results showed that Cimzia rapidly improved the signs and symptoms of PsA for patients with response observed as early as the first week of treatment for some patients," he added.

"UCB has a long heritage in rheumatology, with many years of clinical experience with Cimzia in moderate-to-severe rheumatoid arthritis. This approval represents the third indication for Cimzia in the USA and reaffirms the value of our commitment to developing medicines that treat serious, chronic diseases, and in turn help those with PsA," said Iris Loew-Friedrich, chief medical officer and executive vice president of UCB.