25 July 2017 - The regulatory submissions for this new indication seek to expand the use of Cimzia for the treatment of patients with moderate-to-severe chronic plaque psoriasis.

UCB and Dermira today announced the UCB submission of a supplemental biologics license application to the U.S. FDA for Cimzia (certolizumab pegol). Separately, UCB also submitted a regulatory filing with the EMA. Both regulatory filings seek to expand the approved indications for Cimzia to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. An additional submission to expand the use of Cimzia in this patient population is also planned with Health Canada.

The Phase 3 Cimzia clinical development program in psoriasis was led by Dermira, Inc., in collaboration with UCB as the regulatory sponsor. Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the United States, Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market Cimzia to dermatologists in the United States and Canada. UCB will retain marketing rights for Cimzia in the U.S. and Canada for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis. In the rest of world, UCB retains marketing rights for Cimzia for all approved indications, including psoriasis, subject to approval.

Read UCB press release