US approves UCB’s Cimzia for psoriasis
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.
Read more: http://www.pharmatimes.com/news/us_approves_ucbs_cimzia_for_psoriasis_1237343
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.
Read more: http://www.pharmatimes.com/news/us_approves_ucbs_cimzia_for_psoriasis_1237343