Posted by Michael Wonder on 29 May 2018
UCB announces the approval of Cimzia (certolizumab pegol) for moderate-to-severe plaque psoriasis, representing an important new option for patients in the U.S.
27 May 2018 - The U.S. FDA approval of Cimzia (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry of UCB into immuno-dermatology.
UCB announced today that the U.S. FDA has approved extending the label for Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.
This FDA approval is based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled over 1,000 patients, of whom nearly one third had prior biologic exposure, and confirmed the durable efficacy up to 48 weeks and safety of Cimzia in the treatment of adults with moderate-to-severe plaque psoriasis.
