EU green light for Cimzia to treat psoriasis
The European Medicines Agency has approved a label extension for UCB’s Cimzia allowing its use to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
The approval makes Cimzia (certolizumab pegol), the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists,” the firm noted.
The CIMPASI-1 and -2 and CIMPACT trials confirmed the efficacy and safety of the drug in this setting.
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.
Read more: http://www.pharmatimes.com/news/eu_green_light_for_cimzia_to_treat_psoriasis_1243024
The approval makes Cimzia (certolizumab pegol), the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists,” the firm noted.
The CIMPASI-1 and -2 and CIMPACT trials confirmed the efficacy and safety of the drug in this setting.
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.
Read more: http://www.pharmatimes.com/news/eu_green_light_for_cimzia_to_treat_psoriasis_1243024