31 May 2018 - - Brussels, Belgium-based global biopharmaceutical company UCB (Euronext Brussels: UCB) has received approval from the US Food and Drug Administration (FDA) to extend the label for Cimzia (certolizumab pegol) to include the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, the company said.
This FDA approval is based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT which enrolled over 1,000 patients.
In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48.
Cimzia is the only Fc-free, PEGylated anti-tumor necrosis factor treatment option for this indication.
It has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis, and adults with active ankylosing spondylitis, in addition to an indication for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
UCB is focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.
With more than 7,500 people in approximately 40 countries, the company generated revenue of EUR 4.5bn in 2017.