US regulators have expanded the reach of UCB’s Cimzia, allowing its use to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The anti-inflammatory is already on the market for use in rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis and axial spondyloarthritis.
This latest approval makes Cimzia (certolizumab pegol) the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks UCB’s entry into immuno-dermatology, “where significant unmet need currently exists,” the Beligian drugmaker noted.
The drug’s expanded label rides on the back of positive data from a Phase III clinical development programme consisting of CIMPASI-1, CIMPASI-2 and CIMPACT trials, which enrolled over 1,000 patients, of whom nearly one third had prior biologic exposure.
In all three trials, the drug showed “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, according to the firm.
“The approval of Cimzia for psoriasis and the recent Cimzia label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases are important treatment advances,” stressed Emmanuel Caeymaex, head of Immunology and executive vice president, Immunology Patient Value Unit at UCB.
Psoriasis affects nearly three percent of the population, or around 125 million people worldwide.
“Due to the unique nature of psoriasis, it is critical for dermatologists to have as many options as possible to find the right treatment for each patient”, added Michael Siegel, senior vice President of Research and Clinical Affairs, National Psoriasis Foundation.
“It’s a great day when new psoriasis treatments come to market, as both dermatologists and patients are given hope that this could be the treatment that will work for them.”