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Home Industry News UCB reports filing of Cimzia with EMEA

UCB reports filing of Cimzia with EMEA

2nd July 2008

UCB has announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for Cimzia (certolizumab pegol) as a treatment for patients with moderate to severe active rheumatoid arthritis.

If approved by the agency, the subcutaneous treatment will become the first PEGylated Fc-Free anti-tumour necrosis factor alpha biologic therapy available for this indication in Europe.

The filing of the marketing application is based on a clinical programme involving over 2,300 patients involved in a number of placebo-controlled phase III trials.

In these trials, the compound has been administered both as a monotherapy and in conjunction with methotrexate at two and four-week dosing intervals.

Olav Hellebo, president of inflammation operations for UCB, said: “Along with a fast onset of action, Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function.”

He added that Cimzia will offer a new and effective therapy for the millions of rheumatoid arthritis sufferers worldwide.

In April 2008, UCB hailed the development of Cimzia as a “biological innovation” that will provide doctors and patients with a monthly treatment option for rheumatoid arthritis.

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