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UCB awarded US FDA approval for CIMZIA (certolizumab pegol) to treat moderate-to-severe plaque psoriasis.

M2 EQUITYBITES-May 30, 2018-UCB awarded US FDA approval for CIMZIA (certolizumab pegol) to treat moderate-to-severe plaque psoriasis

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Biopharmaceutical company UCB said on Tuesday that it has received US Food and Drug Administration (FDA) approval for CIMZIA (certolizumab pegol) for use in moderate-to-severe plaque psoriasis, marking its entry into immuno-dermatology programme, where significant unmet need currently exists.

Based in Brussels, Belgium, the company added that the US Food and Drug Administration (FDA) has extended the label for CIMZIA (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis, which follows the recent label update for pregnant and breastfeeding women.

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. CIMZIA is the first Fc-free, PEGylated anti-TNF treatment option for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

This US FDA approval is based on data from the company's Phase 3 clinical development programme consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled over 1,000 patients, of whom nearly one third had prior biologic exposure and confirmed the durable efficacy up to 48 weeks and safety of CIMZIA in the treatment of adults with moderate-to-severe plaque psoriasis, a common, chronic inflammatory disease with primary involvement of the skin.

In conjunction, the CIMZIA Phase 3 psoriasis studies demonstrated significant and clinically meaningful improvements in biologic-naive patients and those previously treated with biologics, with clinical benefit maintained through 48 weeks and the flexibility of two dose regimens that allow for tailored treatment, stated the company.

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Publication:M2 EquityBites (EQB)
Date:May 30, 2018
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