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Psoriasis News

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  • The U.S. Food and Drug Administration’s (FDA) approval of CIMZIA® (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry of UCB into immuno-dermatology
  • CIMZIA Phase 3 psoriasis studies demonstrated significant and clinically meaningful improvements in biologic-naïve patients and those previously treated with biologics, with clinical benefit maintained through 48 weeks and the flexibility of two dose regimens that allow for tailored treatment

Brussels, Belgium – 28th May, 07:00 CEST – UCB announced today that the U.S. Food and Drug Administration (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 (PsO) 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.

“The Phase 3 clinical development program for CIMZIA in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms,” Alice Gottlieb, M.D., Ph.D., Professor of Dermatology at New York Medical College and lead investigator. “Today’s approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control. The two dose regimens of CIMZIA also allow for patient-tailored treatment. CIMZIA also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics.”

Link to Full Media Release

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