UCB files for US and EU approval for Cimzia for psoriatic arthritis and axial spondyloarthritis

Belgium’s largest drugmaker, UCB (Euronext Brussels: UCB) says it has made two new regulatory filings with the US Food and Drug Administration and with the European Medicines Agency to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA). The regulatory filings for two new indications for certolizumab pegol are now under review by the US FDA and EMA.

"We are committed to providing treatments for patients with severe diseases such as PsA and axSpA which can affect adults at a very productive and active time of their lives. These new regulatory filings bring us one step closer to supporting more people living with immunological conditions and to building UCB's immunology franchise," said Iris Loew-Friedrich, chief medical officer and executive vice president UCB.

Novel Ph III trials support the filings