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Positive data for UCB's Cimzia sets up filing in psoriatic arthritis

Phase III backs plans to market drug in extra indication

Belgian pharma company UCB says it is planning to file for approval of its Cimzia product in psoriatic arthritis later this year after a phase III trial backed its efficacy and safety in this setting.

In Europe, Cimzia (certolizumab pegol) is already on the market to treat moderate to severe rheumatoid arthritis in patients who have not responded to disease-modifying anti-rheumatic drugs (DMARDs), while in the US it is approved for rheumatoid arthritis and Crohn's disease.

The decision to press on with filing in the psoriatic arthritis indication follows interim results from the RAPID-PSa study, which shows that the drug achieved a significant improvement in symptoms after 12 weeks of treatment compared to placebo.

The trial is scheduled to continue for 48 weeks and involves 409 patients.

Cimzia is the only pegylated anti-tumour necrosis factor (TNF) treatment on the market, bringing in €221m in the first nine months of 2011, a 60 per cent increase over the same period of 2010 despite a competitive market for biologic treatments for arthritis.

Cimzia competes in this space with blockbusters including Johnson & Johnson's Remicade (infliximab) and Simponi (golimumab), Amgen's Enbrel (etanercept) and Abbott Laboratories' Humira (adalimumab), all of which are already approved to treat psoriatic arthritis.

UCB said last year that in terms of the number of prescriptions written, Cimzia is outpacing the overall arthritis and Crohn's disease market in the US, against a backdrop of slowing anti-TNF sales growth overall.

"We are pleased that Cimzia has the potential to also benefit patients living with psoriatic arthritis and we are currently preparing for submissions to the regulatory authorities later this year," said Iris Loew-Friedrich, UCB's chief medical officer.

"We shall discuss the study results with the regulatory authorities and present them at upcoming major rheumatology congresses," she added.

17th February 2012

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