The U.S. Food and Drug Administration (FDA) has approved extending the label for CIMZIA (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists. The approval also follows a recent FDA label update for CIMZIA in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.
“The Phase 3 clinical development program for CIMZIA in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. 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,” Alice Gottlieb, M.D., Ph.D., Professor of Dermatology at New York Medical College and lead investigator. “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.”
“CIMZIA is the first Fc-free biologic of its kind approved by the FDA to treat this challenging skin condition, building on 10 years of market experience with demonstrated efficacy and established safety across multiple inflammatory diseases. 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,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. “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.”
According to the updated label, the recommended dose of CIMZIA for adults with moderate-to-severe plaque psoriasis is 400 mg (given as two subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), CIMZIA 400 mg (given as two subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week can be considered.
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.
Psoriasis affects nearly three percent of the population, or approximately 125 million people worldwide. Symptoms vary from person to person, but for those who are more severely affected, psoriasis can have a major impact on their quality of life. As many as 42% of patients with psoriasis will develop psoriatic arthritis, 33% will develop metabolic syndrome, and approximately 46% are often or always depressed because of their psoriasis. Despite drug development advances in the past decade, patient survey data suggest that moderate-to-severe psoriasis is being undertreated.
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