FDA approves Cimzia for moderate-to-severe plaque psoriasis.- UCB.

The FDA has approved extending the label for Cimzia (certolizumab pegol), from UCB, 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.

This FDA approval is based on data from a Phase III 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. Each of the three studies included an assessment of the percentage of patients who achieved at least 75% and 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90, respectively) compared to placebo; within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in CIMPACT.

CIMPASI-1, CIMPASI-2 and CIMPACT also assessed the percentage of patients who achieved at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48. These findings and the new approval in psoriasis that they support are significant because they build on four years of efficacy and safety data in psoriatic arthritis (PsA).