Cimzia receives positive CHMP opinion for plaque psoriasis

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UCB’s Cimzia (certolizumab pegol) was recommended for approval by the European Committee for Medicinal Products (CHMP) for the treatment of adult patients with moderate-to-severe plaque psoriasis.

A phase three clinical development program was composed of CIMPASI-1, CIMPASI-2 and CIMPACT, according to a news release. The trials included more than 1,000 patients. In CIMPASI-1 and CIMPASI-2, patients achieved at least 75 percent or greater disease improvement from baseline within 16 weeks. In CIMPACT, patients achieved 75 percent or greater disease improvement within 12 weeks.

“Cimzia demonstrated statistically significant improvements for all primary and coprimary endpoints compared to placebo at all treatment doses, and the clinical benefit was maintained through to week 48,” according to the company.

This approval marks USB’s step into immunodermatology. Cimzia is the first PEGylated anti-TNF agent to earn a positive CHMP recommendation for use in moderate-to-severe plaque psoriasis. The drug also recently received a label update by the European Medicines Agency for use during pregnancy and breastfeeding.

“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,” Emmanuel Caeymaex, head of Immunology and executive vice president, Immunology Patient Value Unit, said in the news release. “This new indication is particularly relevant following the Cimzia label update for pregnancy and breastfeeding, as a significant portion of patients with moderate-to-severe plaque psoriasis are women.”

An endorsement by the European Commission for Cimzia is expected in the second quarter of 2018.