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UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
Date:5/13/2009

- Available this week, Cimzia(R) (certolizumab pegol), the only pegylated anti-TNF, offers a new treatment option for U.S. adult patients suffering from moderately to severely active rheumatoid arthritis

- Patients treated with Cimzia(R), together with methotrexate, experienced rapid and significant improvements in signs and symptoms, physical function and pain as early as week one, and sustained at week 24 and for up to one year

- Patients treated with Cimzia(R) as a monotherapy experienced significant improvements in signs and symptoms, physical function and pain

- Cimzia(R) is available in an exclusively designed, patient-friendly, prefilled syringe resulting from the UCB partnership with OXO(R). The new syringe carries the Arthritis Foundation(TM) Ease-of-Use Commendation

- Cimzia(R) offers U.S. adult patients flexible maintenance dosing, either at two or four weeks after initial doses, and can be used together with methotrexate or as a monotherapy

ATLANTA, May 13 /PRNewswire/ -- regulated information -- UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia(R), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(R) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered.

In clinical trials with Cimzia(R), together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia(R), together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 2
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SOURCE UCB
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