UCB’s Cimzia secures first-of-its-kind FDA approval in plaque psoriasis
pharmafile | May 29, 2018 | News story | Manufacturing and Production, Sales and Marketing | Cimzia, FDA, UCB, US, pharma, psoriasis
The FDA has expanded the label for UCB’s Cimzia (certolizumab pegol) in the US, approving the therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients eligible for systemic therapy or phototherapy, it has emerged.
The decision makes the drug the first Fc-free, PEGylated anti-TNF option available for the treatment of the disease, and was based on Phase 3 data from three studies and over 1,000 patients, nearly a third of whom had previous biologic exposure. The findings confirmed the efficacy of the therapy, which demonstrated “statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses”, with clinically meaningful effects maintained up to 48 weeks.
This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms,” commented Dr Alice Gottlieb, Professor of Dermatology at New York Medical College and lead investigator on the studies. “Today’s approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control. The two dose regimens of Cimzia also allow for patient-tailored treatment. CIMZIA also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics.”
Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB, added: “This approval reflects our heritage of making a difference for specific patient populations with unmet needs, and we are especially gratified to welcome immuno-dermatology patients for the first time to our community of support. The approval of Cimzia for psoriasis and the recent Cimzia label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases are important treatment advances. UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients.”
Matt Fellows
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