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FDA Expands Indication of Psoriasis Drug


May 29, 2018

The US Food and Drug Administration has approved expanding the indication for Cimzia (certolizumab pegol) to include adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The first Fc-free, PEGylated anti-tumor necrosis factor treatment option for this indication, Cimzia was granted approval following a Phase 3 clinical program comprised of 3 trials: CIMPASI-1, CIMPASI, 2, and CIMPACT. Overall, more than 1000 patients were enrolled.

In all 3 trials, Cimzia demonstrated statistically significant improvements in all primary and co-primary endpoints compared with placebo, and a clinically meaningful response was maintained with Cimzia use for up to 48 weeks of use.

On the updated label for Cimzia, the recommended dose for adults with moderate-to-severe plaque psoriasis is 400 mg, administered as 2 subcutaneous injections of 200 mg each, every other week.

A dose of 400 mg Cimzia, administered as 2 subcutaneous injections of 200 mg per dose initially and at weeks 2 and 4, followed by 200 mg every other week, can be considered for some patients with a body weight of approximately 198 lbs (90 kg) or less.

—Christina Vogt


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