FDA approves Cimzia label extension for psoriasis patients

June 25, 2018

Belgian pharmaceutical firm UCB has entered the immunodermatology field in the U.S. market. The Food and Drug Administration (FDA) recently approved extending the label for Cimzia (certolizumab pegol) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy, according to a news release.

Belgian pharmaceutical firm UCB has entered the immunodermatology field in the U.S. market. The Food and Drug Administration (FDA) recently approved extending the label for Cimzia (certolizumab pegol) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy, according to a news release.

With this approval, Cimzia is the first Fc-free, PEGylated anti-tumor necrosis factor (anti-TNF) therapy for this indication. The FDA’s consent follows a phase 3 clinical development program that included more than 1,000 patients in CIMPASI-1, CIMPASI-2 and CIMPACT.

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.

“It’s a great day when new psoriasis treatments come to market, as both dermatologists and patients are given hope that this could be the treatment that will work for them,” Michael Siegel, Ph.D. senior vice president of Research and Clinical Affairs, National Psoriasis Foundation, said in the news release.

Additionally, a recent label update for Cimzia by the FDA includes information for use in pregnant and breastfeeding patients.

“The approval of Cimiza for psoriasis and the recent Cimzia label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases are important treatment advances,” said Emmanuel Caeymaex, executive vice president of Immunology Patient Value Unit and head of Immunology at UCB. “UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients.”

*Original source: *Original source: 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