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UCB Seeks Cimzia Label Expansion

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UCB (UCBJF - Free Report) recently announced new regulatory filings with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for two additional indications for its drug, Cimzia (certolizumab pegol).

The company is looking to get Cimzia approved for the treatment of adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA). UCB’s regulatory filings were based on the phase III RAPID-PsA and RAPID-axSpA studies.

RAPID-PsA was a double-blind, placebo-controlled, phase III study which showed improvements in the signs and symptoms of PsA compared to placebo in adult patients with or without prior anti-TNF (tumor necrosis factor) exposure.

RAPID-axSpA was a randomized, double-blind, placebo-controlled, phase III study which showed that both dosing regimens of Cimzia reduced the signs and symptoms of axSpA as compared to placebo.

We note that UCB’s Cimzia is currently approved in the US for the treatment of moderate-to-severe rheumatoid arthritis patients above 18 years and for reducing the signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in moderate-to-severe CD patients above 18 years, who have failed prior therapy.

Cimzia is also approved in the EU in combination with methotrexate (MTX) for the treatment of moderate-to-severe active rheumatoid arthritis in adults who have responded inadequately to disease-modifying antirheumatic drugs (DMARDs), including MTX. In case of intolerance to MTX or inappropriateness with MTX, Cimzia can be given as monotherapy.

Cimzia sales went up 41% from the year-ago period to €334 million during the first nine months of 2012.

Currently, Abbott Laboratories’ (ABT - Free Report) Humira and Johnson & Johnson’s (JNJ - Free Report) Simponi are marketed drugs in the psoriatic arthritis market.

UCB carries a Zacks Rank #3 (Hold). Right now, Lannett Company, Inc. (LCI - Free Report) looks more attractive with a Zacks Rank #1 (Strong Buy).

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