CHMP recommends approval of Cimzia for moderate-to-severe plaque psoriasis.- UCB.

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label extension for Cimzia (certolizumab pegol), from UCB, 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. The European Commission's endorsement of the CHMP positive opinion for psoriasis is expected in the second quarter of 2018.

The CHMP positive opinion is based on data from a Phase III clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials, which enrolled over 1,000 patients, with and without prior treatment experience with biologic products, confirmed the efficacy and safety of Cimzia in the treatment of adult patients with moderate-to-severe plaque psoriasis. Each of the three studies included an assessment of the percentage of patients who achieved at least 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) compared to placebo; within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in CIMPACT. CIMPASI-1 and CIMPASI-2 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 as a co-primary endpoint. In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all treatment doses, and the clinical benefit was maintained through to week 48.

According to the updated label, the recommended starting dose of Cimzia for adult patients is 400 mg at weeks 0, 2 and 4. After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks. A dose of 400 mg every 2 weeks can be considered in patients with insufficient response.