FDA Expands Indication of Psoriasis Drug
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.
UCB announces the approval of CIMZIA® (certolizumab pegol) for moderate-to-severe plaque psoriasis, representing an important new option for patients in the U.S. [press release]. Brussels, Belgium. UCB. May 28, 2018. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-the-Approval-of-CIMZIA-certolizumab-pegol-for-Moderate-to-Severe-Plaque-Psoriasis-Representing-an-Important-New-Option-for-Patients-in-the-U-S Accessed on May 29, 2018.