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FDA Extends Label for Cimzia for Plaque Psoriasis

UCB news release; 2018 May 29

UCB has that the US 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 (PsO). UCB is headquartered in Brussels, Belgium.

Indications: Cimzia is indicated for the treatment of adults with moderate-to-severe plaque 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. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.

Dosage/administration: The dosage for Cimzia is 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week may be considered.

Adverse reactions: The most common adverse reactions (incidence ≥7% and > than placebo) are: upper respiratory tract infection, rash, and urinary tract infection.

Citation:

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. [news release]. Brussels, Belgium: UCB. May 29, 2018. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/Press-Release. Accessed May 29, 2018.

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