UCB announced on 4/27/18 that the European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label extension for Cimzia (certolizumab pegol), to include a new indication in adult patients with moderate-to-severe plaque psoriasis. Cimzia is the first Fc-free, PEGylated anti-TNF to receive a positive CHMP opinion for use in moderate-to-severe plaque psoriasis.[3] The European Commission's (EC) endorsement of the CHMP positive opinion for psoriasis is expected in the second quarter of 2018 and would further broaden the clinical value of Cimzia.

"The Phase 3 clinical development program for Cimzia in plaque psoriasis demonstrated clinically meaningful improvements in primary efficacy endpoints over a 48-week period, as well as improvements in important patient quality of life measures. The data established the durable clinical benefit of CIMZIA, with all three studies showing that the clinical benefit with CIMZIA was maintained for up to one year. Psoriasis has a significant emotional and physical impact on patients, and there is still a need for new therapies that effectively control skin symptoms over time. The availability of CIMZIA in psoriasis would provide healthcare professionals with an effective, broad spectrum anti-TNF with 10 years of clinical experience to help manage this debilitating condition and improve the quality of patients' lives through durable disease control," said Diamant Thaçi, Professor, MD, Director of the Institute for Inflammatory Medicine, University Hospital Schleswig-Holstein, Campus Lübeck.

"Cimzia is the first anti-TNF of its kind to receive a CHMP positive opinion for this challenging disease. We look forward to offering patients and their dermatologists a new treatment option, with best-in-class efficacy and two different doses to maximize disease control, achieve clear skin and face the serious quality-of-life challenges that often accompany plaque psoriasis. This new indication is particularly relevant following the CIMZIA label update for pregnancy and breastfeeding, as a significant proportion of patients with moderate to severe plaque psoriasis are women, making CIMZIA an optimal treatment for women of childbearing age," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB.